Change in Glycated Haemoglobin (HbA1c) [Noninferiority]
| Group | Value (Percentage point of HbA1c) | Spread |
|---|---|---|
| Insuline Glargine U100 (Reduced) + Semaglutide | -1.37 | 0.84 |
| Insuline Glargine U100 (Titrated) | -0.65 | 0.92 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataUnited States, Czechia, Greece, Italy, Portugal, Puerto Rico, Romania, Russia, Slovakia, South Africa, Spain, Ukraine
1 trial · 1 completed · 1 with posted results
A Research Study to Look Into How Semaglutide, Together With a Lower Dose of Insulin Glargine, Compares to a Higher Dose of Insulin Glargine Alone in People With Type 2 Diabetes (SUSTAIN OPTIMIZE)
NCT0551453529 Aug 2022 to 9 Apr 2025
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study compares semaglutide, together with a lower dose of insulin glargine, to a higher dose of insulin glargine in participants with type 2 diabetes. The study looks at how well the study medicines control blood glucose levels. Participants will either get semaglutide together with a lower dose of insulin glargine or a higher dose of insulin glargine. The study will last for about 47 weeks (approximately 11 months). Participants will have 9 clinic visits, 15 phone/video calls and 1 home visit. Participants will be asked to wear a sensor that measures their blood sugar all the time in 2 periods of 10 days during the study.
Experimental
Insuline glargine U100 (reduced) + semaglutide
Participants will initially receive 0.25 milligrams (mg) once-weekly semaglutide subcutaneously (s.c.) and the dose will be gradually escalated to 2 mg as an add-on to dose-reduced insulin glargine s.c. given once-daily. Insulin glargine U100 will be reduced by 10 U at the initiation of semaglutide and then again at each semaglutide dose escalation. Insulin glargine dose will be adjusted based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values (target SMPG: 4.4-7.2 millimoles per litre (mmol/L)).
Active comparator
Insuline glargine U100 (titrated)
Participants will receive titrated insuline glargine U100 s.c. once-daily. Insulin glargine U100 dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.4-7.2 mmol/L).
Outcomes the sponsor listed as primary.
Change in Glycated Haemoglobin (HbA1c) [Noninferiority]
Time frame · From baseline (week 0) to end of treatment (week 40)
Change in HbA1c (Noninferiority) from baseline (Week 0) to end of treatment (Week 40) were reported. Here noninferiority was assessed based on the clinically acceptable margin of 0.3%-point for the mean treatment difference in HbA1c.
Change in Body Weight
Time frame · From baseline (week 0) to end of treatment (week 40)
Change in body weight from baseline (Week 0) to end of treatment (Week 40) were reported. Body weight was measured in unit 'Kilogram (kg)'.
Percentage Change in Daily Insulin Dose
Time frame · From baseline (week 0) to end of treatment (week 40)
Percentage change in daily insulin dose from baseline (Week 0) to end of treatment (Week 40) were reported. Percentage change from baseline to week 40 in insulin dose (%) was calculated as: (\[insulin dose at week 40\] - \[insulin dose at baseline\]) / \[insulin dose at baseline\] × 100.
Change in Glycated Haemoglobin (HbA1c ) [Superiority]
Time frame · From baseline (week 0) to end of treatment (week 40)
Change in HbA1c (Superiority) from baseline (Week 0) to end of treatment (Week 40) were reported.
Score of Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc)
Time frame · At end of treatment (week 40)
Score of Diabetes Treatment Satisfaction Questionnaire - change version (DTSQc) at end of treatment (week 40) were reported. The DTSQc provided a measure of how satisfied participants were with their current diabetes treatment compared with previous treatment. It consisted of 8 questions, which were to be answered on a Likert scale from -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint) representing no change. Out of 8 questions, 6 questions related to treatment satisfaction were summed to produce a total score. The DTSQc total treatment satisfaction score ranged from -18 to +18, with higher scores associated with greater treatment satisfaction.
Number of Participants Achieving Insulin Dose = 0 Units/mL (U)
Time frame · At end of treatment (week 40)
Number of participants achieving Insulin dose = 0 U at the end of treatment (Week 40) were reported.
Number of Participants Achieving Insulin Dose Reduced From Baseline by at Least 50%
Time frame · At end of treatment (week 40)
Number of participants achieving Insulin dose reduced from baseline by at least 50% by end pf treatment (Week 40) were reported.
Number of Participants Achieving HbA1c Less Than (<) 7%
Time frame · At end of treatment (week 40)
Number of participants achieving HbA1c \< 7% at the end of treatment (Week 40) were reported.
Number of Severe Hypoglycaemic Episodes (Level 3)
Time frame · From baseline (week 0) to end of treatment (week 40)
Number of severe hypoglycaemic episodes (level 3) from baseline (week 0) to end of treatment (week 40) were reported. Severe hypoglycaemia (level 3) was defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery.
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose (BG) Meter)
Time frame · From baseline (week 0) to end of treatment (week 40)
Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL), confirmed by BG meter) from baseline (week 0) to end of treatment (week 40) were reported. Clinically significant hypoglycaemia (level 2) was defined as plasma glucose value of less than (\<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter.
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)
Time frame · From baseline (week 0) to end of treatment (week 40)
Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) from baseline (week 0) to end of treatment (week 40) were reported. Clinically significant hypoglycaemia (level 2) was defined as plasma glucose value of less than (\<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3) was defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery.
Number of Participants Achieving HbA1c Reduced From Baseline by at Least 0.3%-Points and Insulin Dose Reduced From Baseline, No Hypoglycaemic Episodes (< 3.9 mmol/L (70 mg/dL) Confirmed by BG Meter) and No Weight Gain
Time frame · At end of treatment (week 40)
Number of Participants achieving HbA1c reduced from baseline by at least 0.3%-points and Insulin dose reduced from baseline, No hypoglycaemic episodes (\< 3.9 mmol/L (70 mg/dL) confirmed by BG meter) and No weight gain at the end of treatment (Week 40) were reported.
Change in Score of Diabetes Treatment Satisfaction Questionnaire - Status Version (DTSQs)
Time frame · From baseline (week 0) to end of treatment (week 40)
Score of Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) at end of treatment (week 40) were reported. The status version measures a patient's current satisfaction with treatment using a 0-6 scale for each item; higher scores indicate greater satisfaction with the present treatment (absolute/status level). The DTSQs total treatment satisfaction score ranged from 0 to 36, with higher scores associated with greater treatment satisfaction.
Change in Score of Short Form 36 Version 2 (SF-36 v2)
Time frame · From baseline (week 0) to end of treatment (week 40)
Change in SF-36 physical and mental component from baseline (week 0) to end of treatment (Week 40) were presented. SF-36 is self-administered questionnaire that measures each of following 8 health domains: physical functioning, role limitations due to physical problems (role-physical), social functioning, bodily pain, mental health, role limitations due to emotional problems (role-emotional), vitality, and general health perception. There are also 2 component scores derived from the 8 subscale scores: mental component summary and physical component summary. Physical component summary contains physical functioning, role-physical, bodily pain and general health and mental component summary contain vitality, social functioning, role-emotional and mental health. Each SF-36 domain and component summary score ranges from 0 to 100, higher scores reflect better participant health status. A positive change score indicates an improvement since baseline.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Percentage point of HbA1c) | Spread |
|---|---|---|
| Insuline Glargine U100 (Reduced) + Semaglutide | -1.37 | 0.84 |
| Insuline Glargine U100 (Titrated) | -0.65 | 0.92 |
| Group | Value (Kilograms) | Spread |
|---|---|---|
| Insuline Glargine U100 (Reduced) + Semaglutide | -7.97 | 5.62 |
| Insuline Glargine U100 (Titrated) | 0.39 | 4.08 |
| Group | Value (Percentage change of daily insulin dose) | Spread |
|---|---|---|
| Insuline Glargine U100 (Reduced) + Semaglutide | -15.11 | 87.25 |
| Insuline Glargine U100 (Titrated) | 103.42 | 142.38 |
| Group | Value (Percentage-point of HbA1c) | Spread |
|---|---|---|
| Insuline Glargine U100 (Reduced) + Semaglutide | -1.37 | 0.84 |
| Insuline Glargine U100 (Titrated) | -0.65 | 0.92 |
| Group | Value (Score on a scale) | Spread |
|---|---|---|
| Insuline Glargine U100 (Reduced) + Semaglutide | 14.69 | 4.65 |
| Insuline Glargine U100 (Titrated) | 12.11 | 6.84 |
| Group | Value (Participants) |
|---|---|
| Insuline Glargine U100 (Reduced) + Semaglutide | 37 |
| Insuline Glargine U100 (Titrated) | 0 |
| Group | Value (Participants) |
|---|---|
| Insuline Glargine U100 (Reduced) + Semaglutide | 103 |
| Insuline Glargine U100 (Titrated) | 2 |
| Group | Value (Participants) |
|---|---|
| Insuline Glargine U100 (Reduced) + Semaglutide | 224 |
| Insuline Glargine U100 (Titrated) | 111 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| INSULIN GLARGINE (REDUCED) + SEMAGLUTIDEParticipants initially received semaglutide 0.25 mg s.c. OW and were dose-escalated over 12 weeks with increases at Weeks 4, 8, and 12 to reach a maintenance dose of 2.0 mg, as add-on to dose-reduced insulin glargine U100 administered subcutaneously once daily for 40 weeks. | 1 / 288 | 17 / 288 | 92 / 288 |
| INSULIN GLARGINE (TITRATED)Participants received titrated insulin glargine U100 administered s.c. once daily for 40 weeks. | 1 / 284 | 15 / 284 | 13 / 284 |
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