Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes (SUSTAIN™ 4)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Novo Nordisk A/S
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02128932
First received: April 24, 2014
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: semaglutide
Drug: insulin glargine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as Add on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in HbA1c from baseline [ Time Frame: Week 0, week 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in body weight from baseline [ Time Frame: Week 0, week 30 ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose from baseline [ Time Frame: Week 0, week 30 ] [ Designated as safety issue: No ]
  • Change in systolic and diastolic blood pressure from baseline [ Time Frame: Week 0, week 30 ] [ Designated as safety issue: No ]
  • Change in patient reported outcome (PRO) questionnaire SF-36v2™ from baseline [ Time Frame: Week 0, week 30 ] [ Designated as safety issue: No ]
  • Change in patient reported outcome (PRO) questionnaire DTSQs (diabetes treatment satisfaction questionnaire) from baseline [ Time Frame: Week 0, week 30 ] [ Designated as safety issue: No ]
  • Subjects who achieve HbA1c equal to or below 6.5% (48 mmol/mol) American Association of Clinical Endocrinologists (AACE) target: (yes/no) [ Time Frame: After 30 weeks treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 1047
Study Start Date: August 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Semaglutide 0.5 mg/week Drug: semaglutide
Injected subcutaneously (under the skin) once weekly. Following 4 doses (4 weeks) of 0.25 mg semaglutide weekly subjects will receive 0.5 mg semaglutide weekly for 26 weeks.
Experimental: Semaglutide 1.0 mg/week Drug: semaglutide
Injected subcutaneously (under the skin) once weekly. Following 4 doses (4 weeks) of 0.25 mg semaglutide weekly and 4 doses (4 weeks) of 0.5 mg semaglutide subjects will receive 1.0 mg semaglutide weekly for 22 weeks.
Active Comparator: Insulin glargine Drug: insulin glargine
Injected subcutaneously (under the skin) once daily. Subjects will start on 10 IU once daily and the dose will be adjusted according to fasting plasma glucose.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, 18 years or older at the time of signing informed consent
  • Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose
  • HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive

Exclusion Criteria:

  • Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period
  • Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
  • Treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with intercurrent illness
  • History of chronic or idiopathic acute pancreatitis
  • Screening calcitonin value greater than or equal to 50 ng/L
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
  • Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 30 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 Class IV
  • Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
  • Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
  • Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02128932

Contacts
Contact: Novo Nordisk clinicaltrials@novonordisk.com

  Show 149 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02128932     History of Changes
Other Study ID Numbers: NN9535-3625, 2013-004392-12, U1111-1146-0211, NL47781.018.14
Study First Received: April 24, 2014
Last Updated: September 10, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Croatia: Ministry of Health and Social Care
France: Ministry of Health
Germany: Paul-Ehrlich-Institut
India: Ministry of Health
Macedonia, The Former Yugoslav Republic of: Ministry of Health
Mexico: National Institute of Public Health, Health Secretariat
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
South Africa: Medicines Control Council
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014