The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and Metformin Therapy (DUAL™ III)
This study is currently recruiting participants.
Verified May 2013 by Novo Nordisk
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01676116
First received: August 28, 2012
Last updated: May 13, 2013
Last verified: May 2013
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Purpose
This trial is conducted in Europe, Oceania and the United States of America (USA).
The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like peptide-1 (GLP-1) receptor agonist and metformin therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 2 |
Drug: insulin degludec/liraglutide Drug: liraglutide Drug: exenatide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and Metformin Therapy (DUAL™ III -GLP-1 Switch) |
Resource links provided by NLM:
Drug Information available for:
Metformin
Metformin hydrochloride
Insulin human
Exenatide
Liraglutide
U.S. FDA Resources
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Change in glycosylated haemoglobin (HbA1c) from baseline (randomisation, Visit 2) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Responders achieving pre-defined target: HbA1c below 7.0% (53 mmol/mol) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
- Responders achieving pre-defined target: HbA1c below or equal to 6.5% (48 mmol/mol) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
- Change from baseline in body weight [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
- Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
- Number of severe or minor hypoglycaemic episodes [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
- Number of adverse events (AEs) [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
- Change from baseline in patient reported outcomes (PROs) based on the treatment related impact measure - diabetes (TRIM-D) and diabetes treatment satisfaction questionnaire (DTSQ) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 429 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Insulin degludec/liraglutide + metformin |
Drug: insulin degludec/liraglutide
Injected subcutaneously (under the skin) once daily. Dose individually adjusted. Subjects will continue their pre-trial metformin treatment without changing the frequency or dose throughout the trial.
|
| Active Comparator: Liraglutide or exenatide + metformin |
Drug: liraglutide
Subjects will continue on their pre-trial treatment of liraglutide (Victoza®) (GLP-1 receptor agonist) + metformin without changing the frequency or dose throughout the trial.
Drug: exenatide
Subjects will continue on their pre-trial treatment of exenatide (Byetta®) (GLP-1 receptor agonist) + metformin without changing the frequency or dose throughout the trial.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects with type 2 diabetes mellitus
- Glycosylated haemoglobin (HbA1c) 7.0-9.0% (53-75 mmol/mol) (both inclusive)
- Treatment with daily GLP-1 receptor agonist at maximum dose according to local label (i.e. 1.8 mg once daily (OD) Victoza® (liraglutide) or 10 microgram twice daily (BID) Byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg OD Victoza® (liraglutide) or 5 microgram BID Byetta® (exenatide)) in combination with a stable daily dose of metformin (equal to or above 1500 mg or documented maximum tolerated dose) for 90 days or more prior to screening visit (Visit 1)
- BMI (body mass index) equal to or below 40 kg/m^2
Exclusion Criteria:
- Any use of oral anti-diabetic drugs (OADs) (except for metformin) for 90 days or less prior to screening visit (Visit 1)
- Use of any drug (except metformin and GLP-1 receptor agonist) which in the Investigator's opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
- Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator)
- Screening calcitonin equal to or above 50 ng/l
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
- Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary, carotid or peripheral artery revascularisation procedures
- Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigator's opinion
- Subjects with a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the type 2 diabetes mellitus), neurological, genitourinary or haematological system that in the opinion of the Investigator may confound the results of the trial or pose additional risk in administering trial products
- History of chronic pancreatitis or idiopathic acute pancreatitis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676116
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Contacts
| Contact: Novo Nordisk | clinicaltrials@novonordisk.com |
Show 80 Study LocationsSponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Britt Palmer Nielsen | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT01676116 History of Changes |
| Other Study ID Numbers: | NN9068-3851, 2012-000209-63, U1111-1127-1321 |
| Study First Received: | August 28, 2012 |
| Last Updated: | May 13, 2013 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Slovakia: State Institute for Drug Control United States: Food and Drug Administration Hungary: Ministry of Health, Social and Family Affairs |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Exenatide Insulin Metformin |
Glucagon-Like Peptide 1 Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013