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A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide
This study has been completed.
Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00696657
First received: June 11, 2008
Last updated: February 24, 2017
Last verified: February 2017
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Purpose
This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy parameter was HbA1c and the treatment duration was 12 weeks.
| Condition | Intervention | Phase |
|---|---|---|
| Diabetes Diabetes Mellitus, Type 2 | Drug: semaglutide Drug: placebo Drug: liraglutide | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Investigator Primary Purpose: Treatment |
| Official Title: | Investigation of Safety and Efficacy of Five Doses of Semaglutide Versus Placebo and Open-label Liraglutide, as Add on Therapy, in Subjects Diagnosed With Type 2 Diabetes Currently Treated With Metformin or Controlled With Diet and Exercise A 12 Week Multi-centre, Multi National, Double-blind, Placebo-controlled, Randomised, Nine Armed Parallel Group, Dose Finding Trial |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk A/S:
Primary Outcome Measures:
- HbA1c [ Time Frame: after 12 weeks of treatment ]
Secondary Outcome Measures:
- Percentage of subjects with an adverse events [ Time Frame: after 12 weeks of treatment ]
- Percentage of subjects with hypoglycaemic episode [ Time Frame: after 12 weeks of treatment ]
- Change from baseline in ECG [ Time Frame: week 0, week 12 ]
- Change from baseline in vital signs (Pulse) [ Time Frame: week 0, week 12 ]
- Change from baseline in vital signs (blood pressure) [ Time Frame: week 0, week 12 ]
- Change from baseline in standard safety laboratory parameters (haematology) [ Time Frame: week 0, week 12 ]
- Change from baseline in standard safety laboratory parameters ( biochemistry) [ Time Frame: week 0, week 12 ]
- Change from baseline in standard safety laboratory parameters (urinalysis) [ Time Frame: week 0, week 12 ]
- Change from baseline in calcitonin [ Time Frame: week 0, week 12 ]
- Percentage of subjects developing anti-semaglutide antibodies [ Time Frame: after 12 weeks of treatment ]
| Enrollment: | 415 |
| Actual Study Start Date: | June 3, 2008 |
| Study Completion Date: | February 5, 2009 |
| Primary Completion Date: | February 5, 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: semaglutide
0.1 mg, once weekly, s.c. injection
Other Name: NN9535
|
| Experimental: B |
Drug: semaglutide
0.2 mg, once weekly, s.c. injection
Other Name: NN9535
|
| Experimental: C |
Drug: semaglutide
0.4 mg, once weekly, s.c. injection
Other Name: NN9535
|
| Experimental: D |
Drug: semaglutide
0.8 mg, once weekly, s.c. injection
Other Name: NN9535
|
| Experimental: E |
Drug: semaglutide
0.8 mg with titration, once weekly, s.c. injection
Other Name: NN9535
|
| Experimental: F |
Drug: semaglutide
1.6 mg with titration, once weekly, s.c. injection
Other Name: NN9535
|
| Placebo Comparator: G1 |
Drug: placebo
0.1 mg, once weekly, s.c. injection
|
| Placebo Comparator: G2 |
Drug: placebo
0.2 mg, once weekly, s.c. injection
|
| Placebo Comparator: G3 |
Drug: placebo
0.4 mg, once weekly, s.c. injection
|
| Placebo Comparator: G4 |
Drug: placebo
0.8 mg with titration, once weekly, s.c. injection
|
| Placebo Comparator: G5 |
Drug: placebo
0.8 mg with titration, once weekly, s.c. injection
|
| Placebo Comparator: G6 |
Drug: placebo
1.6 mg, once weekly, s.c. injection
|
| Experimental: H |
Drug: liraglutide
1.2 mg with titration, once daily, s.c. injection
|
| Experimental: I |
Drug: liraglutide
1.8 mg with titration, once daily, s.c. injection
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men and women-not-of-childbearing potential diagnosed with type 2 diabetes for at least three months
- Stable treatment regimen with either metformin (at least 1500 mg) or diet and exercise alone for at least three months
- HbA1c: 7.0-10.0 % (both inclusive)
- Body weight between 60 kg and 110 kg
Exclusion Criteria:
- Treatment with insulin, GLP-1 receptor agonists (including liraglutide), dipeptidyl peptidase-4 inhibitors, sulphonylurea, thiazolidinediones, Alpha-GIs, or any investigational drug, within the last three months
- Impaired liver or kidney function
- Proliferative retinopathy or maculopathy requiring acute treatment
- Clinically significant active cardiovascular disease and uncontrolled treated/untreated hypertension
- Recurrent major hypoglycaemia or hypoglycaemic unawareness
- Present or planned use of any drug which could interfere with the glucose levels (e.g. systemic corticosteroids)
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00696657
Show 77 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696657
Show 77 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00696657 History of Changes |
| Other Study ID Numbers: |
NN9535-1821 2007-003956-12 ( EudraCT Number ) |
| Study First Received: | June 11, 2008 |
| Last Updated: | February 24, 2017 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Liraglutide |
Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on June 23, 2017