Change in HbA1c
| Group | Value (percentage of HbA1c) | Spread |
|---|---|---|
| Semaglutide 0.5 mg | -1.51 | 0.06 |
| Semaglutide 1.0 mg | -1.78 | 0.06 |
| Dulaglutide 0.75 mg | -1.11 | 0.05 |
| Dulaglutide 1.5 mg | -1.37 | 0.06 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataShort name SUSTAIN 7
United States, Bulgaria, Croatia, Finland, Germany, Greece, Hong Kong, India, Ireland, Latvia, Lithuania, Portugal, Puerto Rico, Romania, Slovakia, Spain, United Kingdom
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes.
Experimental
Semaglutide 0.5 mg/Week
Experimental
Semaglutide 1.0 mg/Week
Active comparator
Dulaglutide 0.75 mg/Week
Active comparator
Dulaglutide 1.5 mg/Week
Outcomes the sponsor listed as primary.
Change in HbA1c
Time frame · Week 0, week 40
Results are based on HbA1c data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on-treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Change in Body Weight (kg)
Time frame · Week 0, week 40
Results are based on body weight data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication.
Change in Fasting Plasma Glucose
Time frame · Week 0, week 40
Results are based on fasting plasma glucose data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication.
Change in Systolic and Diastolic Blood Pressure
Time frame · Week 0, week 40
Results are based on systolic and diastolic blood pressure data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication.
Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire
Time frame · Week 0, week 40
The questionnaire contains 8 items and evaluates subjects' diabetes treatment in terms of convenience, flexibility and general feelings towards treatment. The result presented is 'Treatment Satisfaction' summary score (sum of 6 of the 8 items). Response options: 6 (best case) to 0 (worst case). Total scores range: 0-36. Higher scores=higher satisfaction. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This includes observations recorded at, or after the date of first dose of trial product and not after first occurrence of following: the end-date of the 'on-treatment' observation period or initiation of rescue medication
HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target
Time frame · After 40 weeks treatment
Percentage of subjects who achieved HbA1c target below or equal to 6.5% (48 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Change From Baseline in 7-point Self-measured Plasma Glucose (SMPG) Mean Profile
Time frame · Week 0, week 40
SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are mean profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Change From Baseline 7-point Self-measured Plasma Glucose Increment
Time frame · Week 0, week 40
SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are plasma glucose incremental profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit
Change in Fasting Blood Lipids (Total Cholesterol)
Time frame · Week 0, week 40
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
Change in Fasting Blood Lipids (Low Density Lipoprotein [LDL] Cholesterol)
Time frame · Week 0, week 40
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
Change in Fasting Blood Lipids (High Density Lipoprotein [HDL] Cholesterol)
Time frame · Week 0, week 40
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
Change in Fasting Blood Lipids (Triglycerides)
Time frame · Week 0, week 40
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
Change in Body Mass Index (BMI)
Time frame · Week 0, week 40
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Change in Waist Circumference
Time frame · Week 0, week 40
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Change in Short Form Health Survey (SF-36v2™)
Time frame · Week 0, week 40
The questionnaire contains 36 items across 8 domains and 2 summary scores. Score range: 0 (worst score) to 100 (best score). Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target
Time frame · After 40 weeks of treatment
Percentage of subjects who achieved HbA1c target below or equal to \<7.0% (53 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5%
Time frame · After 40 weeks treatment
Percentage of subjects who achieved weight loss ≥5% after 40 weeks of treatment. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10%
Time frame · After 40 weeks treatment
Percentage of subjects who achieved weight loss ≥10% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain
Time frame · After 40 weeks of treatment
Percentage of subjects achieved (yes/no) HbA1c \<7.0% (53 mmol/mol) without severe or BG confirmed symptomatic hypoglycaemia episodes and no weight gain after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was subset of 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1%
Time frame · After 40 weeks of treatment
Percentage of subjects who achieved (yes/no) HbA1c reduction of ≥1% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3%
Time frame · After 40 weeks treatment
Percentage of subjects who achieved (yes/no) weight loss of ≥3% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of HbA1c) | Spread |
|---|---|---|
| Semaglutide 0.5 mg | -1.51 | 0.06 |
| Semaglutide 1.0 mg | -1.78 | 0.06 |
| Dulaglutide 0.75 mg | -1.11 | 0.05 |
| Dulaglutide 1.5 mg | -1.37 | 0.06 |
| Group | Value (kg) | Spread |
|---|---|---|
| Semaglutide 0.5 mg | -4.56 | 0.28 |
| Semaglutide 1.0 mg | -6.53 | 0.28 |
| Dulaglutide 0.75 mg | -2.30 | 0.27 |
| Dulaglutide 1.5 mg | -2.98 | 0.27 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Semaglutide 0.5 mg | -2.18 | 0.12 |
| Semaglutide 1.0 mg | -2.83 | 0.12 |
| Dulaglutide 0.75 mg | -1.87 | 0.12 |
| Dulaglutide 1.5 mg | -2.25 | 0.12 |
| Group | Value (mmHg) | Spread |
|---|---|---|
| Semaglutide 0.5 mg | -0.57 | 0.48 |
| Semaglutide 1.0 mg | -2.05 | 0.49 |
| Dulaglutide 0.75 mg | -0.35 | 0.47 |
| Dulaglutide 1.5 mg | -0.03 | 0.47 |
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Semaglutide 0.5 mg | 4.60 | 0.28 |
| Semaglutide 1.0 mg | 4.55 | 0.29 |
| Dulaglutide 0.75 mg | 4.52 | 0.28 |
| Dulaglutide 1.5 mg | 4.65 | 0.28 |
| Group | Value (percentage of subjects) |
|---|---|
| Semaglutide 0.5 mg | 49.2 |
| Semaglutide 1.0 mg | 66.7 |
| Dulaglutide 0.75 mg | 34.1 |
| Dulaglutide 1.5 mg | 47.2 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Semaglutide 0.5 mg | -2.43 | 0.10 |
| Semaglutide 1.0 mg | -2.95 | 0.10 |
| Dulaglutide 0.75 mg | -1.99 | 0.10 |
| Dulaglutide 1.5 mg | -2.32 | 0.10 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Semaglutide 0.5 mg | -0.77 | 0.08 |
| Semaglutide 1.0 mg | -0.93 | 0.09 |
| Dulaglutide 0.75 mg | -0.44 | 0.08 |
| Dulaglutide 1.5 mg | -0.63 | 0.08 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Semaglutide 0.5 mgSubjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for 36 weeks (weeks 5 to 40). | 0 / 301 | 17 / 301 | 132 / 301 |
| Semaglutide 1.0 mgSubjects received s.c. injections of semaglutide OW for treatment duration of 40 weeks. Subjects received semaglutide 0.25 mg for 4 weeks (weeks 1 to 4) followed by 0.5 mg for another 4 weeks (weeks 5 to 8) and then semaglutide 1.0 mg for remaining 32 weeks (weeks 9-40). Subjects were followed for 5 weeks after completion of treatment period. | 1 / 300 | 23 / 300 | 134 / 300 |
| Dulaglutide 0.75 mgSubjects received s.c. injections of dulaglutide 0.75 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | 2 / 299 | 24 / 299 | 106 / 299 |
| Dulaglutide 1.5 mgSubjects received s.c. injections of dulaglutide 1.5 mg OW for treatment duration of 40 weeks. Subjects were followed for 5 weeks after completion of treatment period. | 2 / 299 | 22 / 299 | 139 / 299 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
12 studies on this page
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Rodbard et al. 2019Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologistscited by 17
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Indexing hint: Observational study · 2019
Malkin et al. 2019Advances in therapycited by 11
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Indexing hint: Randomized controlled trial · 2019
Jendle et al. 2019Diabetes, obesity & metabolismcited by 17
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Indexing hint: Randomized controlled trial · 2018
Ahmann et al. 2018Diabetes carecited by 481
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Indexing hint: Randomized controlled trial · 2018
Pratley et al. 2018The lancet. Diabetes & endocrinologycited by 614
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PubMed tag: none · 2018
Wilkinson et al. 2018Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 18
PMID 29557057PMC5984908DOI 10.1007/s13300-018-0402-8PUB-29557057
Indexing hint: Systematic review · 2018
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1 study on this page
Indexing hint: Review · 2019
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