Comparison of Insulin Detemir or Insulin Glargine as Add on to Oral Antidiabetic Drugs in Type 2 Diabetes
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00283751
First received: January 27, 2006
Last updated: June 19, 2012
Last verified: June 2012
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Purpose
This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to test if Insulin Detemir as add-on to current Oral Antidiabetic Drug treatment is at least as effective as Insulin Glargine as add-on to current Oral Antidiabetic Drug treatment in reducing HbA1c in patients with Type 2 Diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 2 |
Drug: insulin detemir Drug: insulin glargine |
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: | Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine as Add-on to Current Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- HbA1c [ Time Frame: after 52 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Insulin antibodies [ Designated as safety issue: No ]
- Incident of hypoglycaemic episodes and adverse events [ Designated as safety issue: Yes ]
- Plasma glucose profiles [ Designated as safety issue: No ]
- Change in body weight [ Designated as safety issue: No ]
| Enrollment: | 583 |
| Study Start Date: | March 2003 |
| Study Completion Date: | November 2004 |
| Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 2 Diabetes for more than 12 months, and no previous insulin treatment
- Oral Antidiabetic Drug treatment for at least 4 months
- Body Mass Index (BMI) less than 40 kg/m2
- HbA1c 7.5-10.0%
Exclusion Criteria:
- Current or previous treatment with thiazolidinediones within the last 6 months
- Oral Antidiabetic Drug treatment with combination of three or more Oral Antidiabetic Drugs within the last 6 months
- Proliferative retinopathy or maculopathy
- Known hypoglycaemia unawareness
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00283751
Locations
| United States, Nevada | |
| Novo Nordisk Clinical Trial Call Center | |
| Las Vegas, Nevada, United States, 89103 | |
| Austria | |
| Vienna, Austria | |
| Belgium | |
| Leuven, Belgium | |
| France | |
| Bondy, France | |
| Germany | |
| Heidelberg, Germany | |
| Ireland | |
| Dublin, Ireland | |
| United Kingdom | |
| Leicester, United Kingdom | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Per Clauson, MD, PhD | Novo Nordisk |
More Information
Additional Information:
No publications provided by Novo Nordisk
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00283751 History of Changes |
| Other Study ID Numbers: | NN304-1373 |
| Study First Received: | January 27, 2006 |
| Last Updated: | June 19, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Austria: Federal Ministry for Health and Women Ireland: Irish Medicines Board United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glargine |
Insulin Hypoglycemic Agents Insulin, Long-Acting Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013