A Trial Investigating the Effects of Semaglutide on ß-cell Function in Subjects With Type 2 Diabetes

NCT02212067 | Completed Phase 1

• 3 other identifiers: NN9535-36352013-002173-22U1111-1143-1206
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Europe. The aim of the trial is to investigate the effects of semaglutide on ß-cell function in subjects with type 2 diabetes.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Area under the serum insulin concentration time curve from 0 to 10 minutes after a 25 g glucose bolus i.v. infusion (IVGTT,intravenous glucose tolerance test) over 2 minutes

  Day -1, day 86

• Area under the serum insulin concentration time curve from 10-120 minutes after a 25 g glucose bolus i.v. infusion (IVGTT).

  Day -1, day 86

Secondary Outcomes (6)

• Area under the insulin secretion rate (ISR)-time curve within 0 to 10 min after i.v. glucose challenge

  Day -1, day 86

• Area under the ISR-time curve within 10 to 120 min after i.v. glucose challenge

  Day -1, day 86

• 24-hour plasma glucose, glucagon, serum insulin, and C-peptide measured as total AUC0-24h during a test day with 3 standardised meals

  Day -1, day 85

• Area under the insulin secretion rate (ISR)-time curve within 0 to 10 min after i.v. arginine application; ISR will be derived from the C-peptide concentration profile

  Day -1, day 86

• Area under the ISR curve over the 5-12 mmol/L (90-216 mg/dL) glucose interval; ISR will be derived from the C-peptide concentration profile

  Day -1, day 87

Study Arms (3)

Semaglutide

EXPERIMENTAL

Total of 12 visits

Drug: semaglutide

Placebo

PLACEBO COMPARATOR

Total of 12 visits

Drug: placebo

Healthy subjects

NO INTERVENTION

Total of 2 visits

Interventions

semaglutide DRUG

Administered subcutaneously (s.c., under the skin) once weekly for 12 weeks.

Semaglutide

placebo DRUG

Administered subcutaneously (s.c., under the skin) once weekly for 12 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-64 years (both inclusive) at the time of signing the informed consent
• For subjects with type 2 diabetes:
• Male and female subjects diagnosed with type 2 diabetes
• Treated with diet and exercise and/or metformin monotherapy. Metformin dose should be unchanged in a period of 30 days prior to screening
• Body Mass Index (BMI) between 20.0-35.0 kg/m\^2 (both inclusive)
• Glycosylated haemoglobin (HbA1c) between 6.5-9.0 % (both inclusive)
• For healthy control group for graded glucose infusion:
• Healthy male and female subjects
• BMI between 24.0-32.0 kg/m\^2 (both inclusive)
• HbA1c less than 6.5 %

You may not qualify if:

• Female who is pregnant, breast-feeding or intends to become pregnant or is of child bearing potential and not using an adequate contraceptive method. Women of child bearing potential must use an effective method of birth control for the duration of the trial and for subjects with type 2 diabetes for 5 weeks following the last dose of semaglutide. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices), or sexual abstinence or vasectomised partner
• Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiac, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic
• Use of any prescription or non-prescription medication which could interfere with trial pharmacokinetic or pharmacodynamic results, as judged by the investigator or specifically: a) current treatment with systemic (oral or i.v.) corticosteroids, non-selective betablockers, b) thyroid hormones are not allowed unless the use of these have been stable during the past 2 month prior to screening
• History of drug/chemical substance abuse within 1 year prior to screening, or a positive result in the urine drug test
• History of alcohol abuse within 1 year prior to screening, or a positive result in the alcohol breath test
• Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
• Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Publications (1)

• Kapitza C, Dahl K, Jacobsen JB, Axelsen MB, Flint A. Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial. Diabetologia. 2017 Aug;60(8):1390-1399. doi: 10.1007/s00125-017-4289-0. Epub 2017 May 19.

  PMID: 28526920 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 8, 2014
• Study Start: August 11, 2014
• Primary Completion: May 11, 2015
• Study Completion: May 11, 2015
• Last Updated: March 7, 2018

Record last verified: 2018-03

Locations

DE (1)