Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes (SUSTAIN™ 2)
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ClinicalTrials.gov Identifier: NCT01930188 |
Recruitment Status :
Completed
First Posted : August 28, 2013
Results First Posted : January 7, 2019
Last Update Posted : June 13, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Diabetes Mellitus, Type 2 | Drug: semaglutide Drug: sitagliptin Drug: placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1231 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes (SUSTAIN™ 2 - vs. DPP-4 Inhibitor) |
Actual Study Start Date : | December 2, 2013 |
Actual Primary Completion Date : | October 12, 2015 |
Actual Study Completion Date : | October 12, 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Semaglutide 0.5 mg + sitagliptin placebo |
Drug: semaglutide
For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication. Drug: placebo Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication. |
Experimental: Semaglutide 1.0 mg + sitagliptin placebo |
Drug: semaglutide
For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication. Drug: placebo Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication. |
Active Comparator: Sitagliptin 100 mg + semaglutide placebo 1.0 mg |
Drug: sitagliptin
Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication. Drug: placebo For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication. |
Active Comparator: Sitagliptin 100 mg + semaglutide placebo 0.5 mg |
Drug: sitagliptin
Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication. Drug: placebo For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication. |
- Change in HbA1c (Glycosylated Haemoglobin) From Baseline [ Time Frame: Week 0, week 56 ]Change in HbA1c from baseline until week 56.Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of randomised semaglutide or sitagliptin.
- Change in Body Weight From Baseline [ Time Frame: Week 0, week 56 ]Change in body weight from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin.
- Change in Fasting Plasma Glucose (FPG) From Baseline [ Time Frame: Week 0, week 56 ]Change in fasting plasma glucose from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin.
- Change in Systolic and Diastolic Blood Pressure From Baseline [ Time Frame: Week 0, week 56 ]Change in systolic and diastolic blood pressure from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin
- Change in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) From Baseline [ Time Frame: Week 0, week 56 ]Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin. The DTSQs questionnaire was used to assess subjects' treatment satisfaction. This questionnaire contained 8 components and evaluates the diabetes treatment (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings towards the treatment. The result presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction.
- Subjects Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target (Yes/no) [ Time Frame: After 56 weeks treatment ]Subjects who achieved HbA1c ≤6.5% (48 mmol/mol) American Association of Clinical Endocrinologists (AACE) target (yes/no) after week 56 weeks of treatment.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930188

Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT01930188 |
Other Study ID Numbers: |
NN9535-3626 2012-004827-19 ( EudraCT Number ) U1111-1135-8730 ( Other Identifier: WHO ) 132366 ( Other Identifier: JapicCTI ) CTRI/2014/05/004626 ( Registry Identifier: Clinical Trial Registry India (CTRI) ) |
First Posted: | August 28, 2013 Key Record Dates |
Results First Posted: | January 7, 2019 |
Last Update Posted: | June 13, 2019 |
Last Verified: | May 2019 |
Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Sitagliptin Phosphate Hypoglycemic Agents Physiological Effects of Drugs |
Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |