Primary outcomeMean· Week 0, week 40
Change in HbA1c
| Group | Value (Percentage change) | Spread |
|---|---|---|
| Semaglutide 1.0 mg | -2.0 | 1.0 |
| Semaglutide 2.0 mg | -2.2 | 1.0 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataA Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes
Short name SUSTAIN FORTE
NCTNCT03989232 (opens ClinicalTrials.gov in a new tab)Other idNN9535-4506Other idU1111-1224-5162Other id2018-004529-96Other id2018
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 961 participants (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Design
- Randomized · Quadruple masking
- Countries
11 countries
United States, Bulgaria, Canada, Czechia, Greece, Hungary, Japan, Poland, Puerto Rico, Slovakia, Ukraine
- Start
- 19 Jun 2019
- Primary completion
- 18 Sept 2020
- Completion
- 9 Nov 2020
- First posted
- 18 Jun 2019
- Last update posted
- 13 Feb 2023
- Conditions
- Diabetes Mellitus, Type 2
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201920202021
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study compares the effect of two doses of semaglutide (1.0 mg and 2.0 mg) in people with type 2 diabetes (T2D). People taking part in the study will take the medicine together with their current diabetes medicine (sulphonylurea and/or metformin). Participants will get a dose of either 1.0 mg or 2.0 mg semaglutide once a week - which dose is decided by chance. Participants will inject semaglutide under the skin once a week. The study will last for about 49 weeks. Participants will have 9 clinic visits and 2 phone calls with the study doctor. At the visits participants will have blood taken and eye tests done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Female participants who can get pregnant will be checked 11 times for pregnancy via urine tests.
Interventions
- SemaglutideDrug
- Placebo (semaglutide)Drug
Arms2
Experimental
Semaglutide 2.0 mg
All participants will receive one injection per week during a 12-week dose escalation period, until the target dose for semaglutide 2.0 mg is reached. From week 13 to week 40, semaglutide will be given in two weekly injections of 1.0 mg each.
Active comparator
Semaglutide 1.0 mg
All participants will receive one injection per week during a 12-week dose escalation period. From week 13 to week 40, the 1.0 mg group will receive an additional injection of semaglutide placebo in order to maintain the blinding.
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in HbA1c
Time frame · Week 0, week 40
Registry description
Change from baseline (week 0) to week 40 in glycosylated haemoglobin (HbA1c) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.
Secondary outcomes(10)
Change in Body Weight
Time frame · Week 0, week 40
Registry description
Change from baseline (week 0) to week 40 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.
Change in Fasting Plasma Glucose (FPG)
Time frame · Week 0, week 40
Registry description
Change from baseline (week 0) to week 40 in FPG was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.
Change in Body Mass Index (BMI)
Time frame · Week 0, week 40
Registry description
Change from baseline (week 0) to week 40 in BMI was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.
Change in Waist Circumference
Time frame · Week 0, week 40
Registry description
Change from baseline (week 0) to week 40 in waist circumference was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first.
Participants Who Achieved HbA1c < 7.0%
Time frame · Week 40
Registry description
Percentage of participants who achieved HbA1c \< 7.0% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing HbA1c assessment at week 40 was imputed using observed data from participants within same treatment group.
Participants Who Achieved HbA1c ≤ 6.5%
Time frame · Week 40
Registry description
Percentage of participants who achieved HbA1c ≤ 6.5% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing HbA1c assessment at week 40 was imputed using observed data from participants within same treatment group.
Participants Who Achieved Weight Loss ≥5%
Time frame · Week 40
Registry description
Percentage of participants who achieved weight loss ≥5% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing body weight assessment at week 40 was imputed using observed data from participants within same treatment group.
Participants Who Achieved Weight Loss ≥10%
Time frame · Week 40
Registry description
Percentage of participants who achieved weight loss ≥10% is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first. Missing body weight assessment at week 40 was imputed using observed data from participants within same treatment group.
Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Time frame · Week 0 to week 47
Registry description
Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that required assistance from another person for recovery and blood glucose-confirmed by a plasma glucose value \<3.1 mmol/L (56 milligrams per deciliter (mg/dL)) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period, which started at the date of first dose of trial product and ended at the first date of any of the following: the follow-up visit (week 47), the treatment discontinuation follow-up visit (end of treatment + 7 weeks), the date of last dose of trial product +49 days or the end-date for the 'in-trial' observation period.
Change in Pulse Rate
Time frame · Week 0, week 40
Registry description
Change from baseline (week 0) to week 40 in pulse rate is presented. Results are based on the 'on-treatment' observation period, which started at the date of first dose of trial product and ended at the endpoint-specific end-date.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· Week 0, week 40
Change in Body Weight
| Group | Value (Kilogram (kg)) | Spread |
|---|---|---|
| Semaglutide 1.0 mg | -6.0 | 5.8 |
| Semaglutide 2.0 mg | -7.0 | 5.8 |
Secondary outcomeMean· Week 0, week 40
Change in Fasting Plasma Glucose (FPG)
| Group | Value (Millimoles per liter (mmol/L)) | Spread |
|---|---|---|
| Semaglutide 1.0 mg | -3.2 | 2.8 |
| Semaglutide 2.0 mg | -3.4 | 3.1 |
Secondary outcomeMean· Week 0, week 40
Change in Body Mass Index (BMI)
| Group | Value (Kilogram per squaremeter (Kg/m^2)) | Spread |
|---|---|---|
| Semaglutide 1.0 mg | -2.1 | 2.1 |
| Semaglutide 2.0 mg | -2.5 | 2.1 |
Secondary outcomeMean· Week 0, week 40
Change in Waist Circumference
| Group | Value (Centimeter (cm)) | Spread |
|---|---|---|
| Semaglutide 1.0 mg | -5.2 | 6.1 |
| Semaglutide 2.0 mg | -5.9 | 6.2 |
Secondary outcomeNumber· Week 40
Participants Who Achieved HbA1c < 7.0%
| Group | Value (Percentage of participants) |
|---|---|
| Semaglutide 1.0 mg | 57.5 |
| Semaglutide 2.0 mg | 67.6 |
Secondary outcomeNumber· Week 40
Participants Who Achieved HbA1c ≤ 6.5%
| Group | Value (Percentage of participants) |
|---|---|
| Semaglutide 1.0 mg | 38.5 |
| Semaglutide 2.0 mg | 51.7 |
Secondary outcomeNumber· Week 40
Participants Who Achieved Weight Loss ≥5%
| Group | Value (Percentage of participants) |
|---|---|
| Semaglutide 1.0 mg | 51.3 |
| Semaglutide 2.0 mg | 59.2 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Semaglutide 1.0 mgParticipants received subcutaneous (s.c.) injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target dose of 1.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 1.0 mg semaglutide along with s.c. injection of placebo matched to semaglutide 1.0 mg during 12-40 weeks. | 1 / 480 | 25 / 480 | 126 / 480 |
| Semaglutide 2.0 mgParticipants received s.c. injection of semaglutide once-weekly for 40 weeks in a fixed-dose escalation regimen, with dose doubling every 4 weeks until the target maintenance dose of 2.0 mg was reached: 0.25 mg during 0-4 weeks followed by 0.5 mg during 4-8 weeks followed by 1.0 mg during 8-12 weeks and then 2.0 mg during 12-40 weeks. | 2 / 479 | 21 / 479 | 132 / 479 |
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
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2021
7 results
Efficacy and safety of once-weekly semaglutide 2·0 mg versus 1·0 mg in patients with type 2 diabetes (SUSTAIN FORTE): a double-blind, randomised, phase 3B trial.
Frías et al. 2021The lancet. Diabetes & endocrinologycited by 152
PMID 34293304DOI 10.1016/s2213-8587(21)00174-1PUB-34293304
Full text at the publisher7 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Male or female, age equal to or above18 years at the time of signing informed consent
* Diagnosed with T2D at least 180 days prior to the day of screening
* HbA1c of 8-10% (64-86 mmol/mol) (both inclusive)
* Stable daily dose(s) for 90 days prior to the day of screening of:
* Any metformin formulations (equal to or above1500 mg or maximum tolerated or effective dose) alone or in combination with sulfonylureas (SU) (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose)
Exclusion Criteria:
* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes
* Renal impairment measured as estimated glomerular filtration rate (eGFR) value of \<30 mL/min/1.73 m\^2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKDEPI) creatinine equation as defined by KDIGO 2012 classification
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
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