Phase 3
Completed N=868
Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin in Subjects With Type 2 Diabetes (SUSTAIN - CHINA MRCT)
Source: ClinicalTrials.gov NCT03061214 ↗Enrolled (actual)
868
Serious AEs
5.7%
Results posted
Apr 2020
Primary outcomePrimary: Change in HbA1c — -1.5; -1.8; -1.0; -1.5 Percentage of glycosylated haemoglobin — p=<.0001
◆ Published Evidence
Highly cited
102citations · ~20 / year
Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as add-on to metformin in patients with type 2 diabetes in SUSTAIN China: A 30-week, double-blind, phase 3a, randomized trial.
Summary
This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus sitagliptin 100 mg once-daily on glycaemic control after 30 weeks of treatment. Subjects will remain on their stable pre-trial metformin.
Linked Publications (2)
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Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as add-on to metformin in patients with type 2 diabetes in SUSTAIN China: A 30-week, double-blind, phase 3a, randomized trial.
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Efficacy and Safety of Once-Weekly Semaglutide Versus Once-Daily Sitagliptin as Metformin Add-on in a Korean Population with Type 2 Diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c |
-1.5; -1.8; -1.0; -1.5; -1.7; -0.9 | <.0001 sig |
| SECONDARY Change in Body Weight |
-3.0; -4.2; -0.4 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) |
-2.18; -2.62; -1.0 | — |
| SECONDARY Change in Self-measured Plasma Glucose (SMPG) - Mean 7-point Profile |
-2.5; -3.3; -1.6 | — |
| SECONDARY Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals |
-1.0; -1.2; -0.7 | — |
| SECONDARY Change in Fasting Insulin - Ratio to Baseline |
1.06; 1.03; 1.01 | — |
| SECONDARY Change in Fasting C-peptide - Ratio to Baseline |
1.08; 1.05; 1.0 | — |
| SECONDARY Change in Fasting Glucagon - Ratio to Baseline |
0.89; 0.89; 0.93 | — |
| SECONDARY Change in Fasting Proinsulin - Ratio to Baseline |
0.68; 0.59; 0.81 | — |
| SECONDARY Change in Fasting Proinsulin/Insulin Ratio - Ratio to Baseline |
0.63; 0.57; 0.80 | — |
| SECONDARY Change in Fasting HOMA-B (Beta-cell Function) - Ratio to Baseline |
1.81; 1.95; 1.25 | — |
| SECONDARY Change in Fasting HOMA-IR (Insulin Resistence) - Ratio to Baseline |
0.81; 0.74; 0.90 | — |
| SECONDARY Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score |
1.3; 1.1; 0.0; 0.6; 0.9; -0.3 | — |
| SECONDARY Change in Patient Reported Outcome Questionnaire: DTSQs Score |
-1.4; -1.6; -1.0; -0.1; -0.3; -0.1 | — |
| SECONDARY Change in High-sensitivity CRP - Ratio to Baseline |
0.73; 0.64; 0.96 | — |
| SECONDARY Change in Waist Circumference |
-2.7; -4.0; -0.7 | — |
| SECONDARY Change in BMI |
-1.1; -1.6; -0.1 | — |
| SECONDARY Change in Fasting Total Cholesterol - Ratio to Baseline |
0.95; 0.95; 1.00 | — |
| SECONDARY Change in Fasting LDL Cholesterol - Ratio to Baseline |
0.97; 0.99; 1.01 | — |
| SECONDARY Change in Fasting VLDL Cholesterol - Ratio to Baseline |
0.86; 0.82; 0.93 | — |
| SECONDARY Change in Fasting HDL Cholesterol - Ratio to Baseline |
1.00; 1.02; 1.01 | — |
| SECONDARY Change in Fasting Triglycerides - Ratio to Baseline |
0.86; 0.81; 0.93 | — |
| SECONDARY Change in Free Fatty Acids - Ratio to Baseline |
0.78; 0.78; 0.87 | — |
| SECONDARY Change in Blood Pressure (Systolic and Diastolic Blood Pressure) |
-3.4; -6.5; -0.9; -0.7; -1.5; -0.8 | — |
| SECONDARY Percentage of Participants Who Achieved HbA1c <7.0% (53 mmol/Mol), ADA Target, (Yes/no) |
74.5; 84.0; 49.6; 25.5; 16.0; 50.4 | — |
| SECONDARY Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/Mol), AACE Target, (Yes/no) |
60.4; 70.6; 31.6; 39.6; 29.4; 68.4 | — |
| SECONDARY Percentage of Participants That Achieved (Yes/no): HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemia and no Weight Gain |
66.0; 76.9; 33.7; 34.0; 23.1; 66.3 | — |
| SECONDARY Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥5% |
36.6; 52.7; 5.9; 63.4; 47.3; 94.1 | — |
| SECONDARY Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥10% |
9.7; 17.2; 0.4; 90.3; 82.8; 99.6 | — |
| SECONDARY Total Number of Treatment Emergent Adverse Events |
729; 788; 596 | — |
| SECONDARY Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes |
3; 7; 5 | — |
| SECONDARY Participants With Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes |
2; 6; 4 | — |
| SECONDARY Change in Haematological Parameter: Haemoglobin - Ratio to Baseline |
1.00; 1.00; 1.00 | — |
| SECONDARY Change in Haematological Parameter: Haematocrit - Ratio to Baseline |
1.00; 1.00; 1.00 | — |
| SECONDARY Change in Hematological Parameter: Thrombocytes - Ratio to Baseline |
1.01; 1.01; 0.99 | — |
| SECONDARY Change in Hematological Parameter: Erythrocytes - Ratio to Baseline |
0.99; 0.99; 0.99 | — |
| SECONDARY Change in Hematological Parameter: Leukocytes - Ratio to Baseline |
1.03; 1.01; 1.08 | — |
| SECONDARY Change in Hematological Parameter (Differential Cell Count of Leukocytes): Basophils - Ratio to Baseline |
0.91; 0.80; 0.83 | — |
| SECONDARY Change in Hematological Parameter (Differential Cell Count of Leukocytes): Neutrophils - Ratio to Baseline |
1.01; 1.02; 1.02 | — |
| SECONDARY Change in Hematological Parameter (Differential Cell Count of Leukocytes): Eosinophils - Ratio to Baseline |
0.98; 1.04; 1.00 | — |
| SECONDARY Change in Hematological Parameter (Differential Cell Count of Leukocytes): Monocytes - Ratio to Baseline |
0.96; 0.98; 1.04 | — |
| SECONDARY Change in Hematological Parameter (Differential Cell Count of Leukocytes): Lymphocytes - Ratio to Baseline |
1.01; 0.98; 0.97 | — |
| SECONDARY Change in Biochemistry Parameter: Amylase - Ratio to Baseline |
1.17; 1.19; 1.10 | — |
| SECONDARY Change in Biochemistry Parameter: Lipase - Ratio to Baseline |
1.33; 1.42; 1.24 | — |
| SECONDARY Change in Biochemistry Parameter: Alkaline Phosphatase - Ratio to Baseline |
0.92; 0.91; 0.92 | — |
| SECONDARY Change in Biochemistry Parameter: Alanine Aminotransferase - Ratio to Baseline |
0.86; 0.83; 0.95 | — |
| SECONDARY Change in Biochemistry Parameter: Aspartate Aminotransferase - Ratio to Baseline |
0.92; 0.88; 0.99 | — |
| SECONDARY Change in Biochemistry Parameter: Total Bilirubin - Ratio to Baseline |
0.93; 0.93; 0.93 | — |
| SECONDARY Change in Biochemistry Parameter: Calcium (Corrected)- Ratio to Baseline |
1.01; 1.01; 1.01 | — |
| SECONDARY Change in Biochemistry Parameter: Total Calcium - Ratio to Baseline |
1.02; 1.01; 1.01 | — |
| SECONDARY Change in Biochemistry Parameter: Potassium - Ratio to Baseline |
1.01; 1.00; 1.00 | — |
| SECONDARY Change in Biochemistry Parameter: Sodium - Ratio to Baseline |
1.01; 1.00; 1.00 | — |
| SECONDARY Change in Biochemistry Parameter: Albumin - Ratio to Baseline |
1.02; 1.02; 1.01 | — |
| SECONDARY Change in Biochemistry Parameter: Creatine Kinase - Ratio to Baseline |
1.02; 0.96; 1.07 | — |
| SECONDARY Change in Biochemistry Parameter: Total Protein- Ratio to Baseline |
1.01; 1.00; 1.01 | — |
| SECONDARY Change in Biochemistry Parameter: Creatinine - Ratio to Baseline |
1.08; 1.07; 1.05 | — |
| SECONDARY Change in Biochemistry Parameter: Urea - Ratio to Baseline |
1.01; 1.02; 1.01 | — |
| SECONDARY Change in Biochemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) - Ratio to Baseline |
0.92; 0.92; 0.94 | — |
| SECONDARY Change in Calcitonin - Ratio to Baseline |
0.96; 1.00; 0.96 | — |
| SECONDARY Change in Urinalysis Parameter - UACR-ratio to Baseline |
0.77; 0.69; 0.89 | — |
| SECONDARY Change in Urinalysis Parameter: Glucose |
189; 187; 176; 28; 27; 42 | — |
| SECONDARY Change in Urinalysis Parameter: pH |
0; 0; 0; 17; 15; 14 | — |
| SECONDARY Change in Urinalysis Parameter: Protein |
231; 233; 235; 31; 32; 30 | — |
| SECONDARY Change in Urinalysis Parameter: Ketones |
267; 268; 274; 11; 17; 9 | — |
| SECONDARY Change in Urinalysis Parameter: Erythrocytes |
251; 250; 253; 25; 20; 19 | — |
| SECONDARY Change in Clinical Evaluation: Pulse |
3.7; 3.7; 0.2 | — |
| SECONDARY Change in Clinical Evaluation: ECG |
191; 196; 185; 72; 68; 76 | — |
| SECONDARY Change in Clinical Evaluation: Eye Examinations |
202; 222; 202; 40; 32; 47 | — |
| SECONDARY Change in Physical Examination |
282; 283; 281; 3; 7; 8 | — |
| SECONDARY Anti-semaglutide Antibody Levels |
2.8; 3.3 | — |
| SECONDARY Occurence of Anti-semaglutide Antibodies (Yes/no) |
0; 1; 285; 288; 1; 0 | — |
| SECONDARY Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) |
0; 0; 285; 289; 0; 0 | — |
| SECONDARY Occurence of Anti-semaglutide Antibodies Cross Reacting With Endogenous GLP-1 (Yes/no) |
0; 1; 262; 263 | — |
| SECONDARY Occurence of Cross Reacting Antibodies With in Vitro Neutralising Effect to Endogenous GLP-1 (Yes/no) |
0; 0; 262; 264 | — |
Eligibility Criteria
Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Male or female, age equal to or above 18 years at the time of signing informed consent - Subjects diagnosed with type 2 diabetes and on stable treatment in a period of 60 days prior to screening with metformin equal to or above 1500 mg (or maximum tolerated dose equal to or above 1000 mg). Stable is defined as unchanged medication and unchanged daily dose - HbA1c 7.0 - 10.5 % (53-91 mmol/mol) (both inclusive) Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential not using an adequate contraceptive method throughout the trial including the 5 week follow-up period (adequate contraceptive measure as required by local regulation or practice) - Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol - Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 60 days before screening. An exception is short-term treatment (equal to or below 7 days in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value equal to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version) - Acute coronary or cerebrovascular event within 90 days before randomisation - Heart failure, New York Heart Association (NYHA) class IV
Data sourced from ClinicalTrials.gov (NCT03061214) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.