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

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ClinicalTrials.gov Identifier: NCT02212067
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: semaglutide Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Single-centre, Randomised, Double-blind, Multiple-dose, Placebo-controlled, Parallel-group Trial Investigating the Effects of Semaglutide on ß-cell Function in Subjects With Type 2 Diabetes
Actual Study Start Date : August 11, 2014
Actual Primary Completion Date : May 11, 2015
Actual Study Completion Date : May 11, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: Semaglutide
Total of 12 visits
Drug: semaglutide
Administered subcutaneously (s.c., under the skin) once weekly for 12 weeks.

Placebo Comparator: Placebo
Total of 12 visits
Drug: placebo
Administered subcutaneously (s.c., under the skin) once weekly for 12 weeks.

No Intervention: Healthy subjects
Total of 2 visits



Primary Outcome Measures :
  1. 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 [ Time Frame: Day -1, day 86 ]
  2. Area under the serum insulin concentration time curve from 10-120 minutes after a 25 g glucose bolus i.v. infusion (IVGTT). [ Time Frame: Day -1, day 86 ]

Secondary Outcome Measures :
  1. Area under the insulin secretion rate (ISR)-time curve within 0 to 10 min after i.v. glucose challenge [ Time Frame: Day -1, day 86 ]
  2. Area under the ISR-time curve within 10 to 120 min after i.v. glucose challenge [ Time Frame: Day -1, day 86 ]
  3. 24-hour plasma glucose, glucagon, serum insulin, and C-peptide measured as total AUC0-24h during a test day with 3 standardised meals [ Time Frame: Day -1, day 85 ]
  4. 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 [ Time Frame: Day -1, day 86 ]
  5. 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 [ Time Frame: Day -1, day 87 ]
  6. Slope of the ISR vs. glucose curve (dose-response relationship) [ Time Frame: Day -1, day 87 ]


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 %

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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): NCT02212067


Locations
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Germany
Novo Nordisk Investigational Site
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02212067     History of Changes
Other Study ID Numbers: NN9535-3635
2013-002173-22 ( EudraCT Number )
U1111-1143-1206 ( Other Identifier: WHO )
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases