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| Sponsored by: |
Steno Diabetes Center |
|---|---|
| Information provided by: | Steno Diabetes Center |
| ClinicalTrials.gov Identifier: | NCT00118963 |
Purpose
Aim:
The United Kingdom Prospective Diabetes Study (UKPDS) showed a reduction in cardiovascular events in obese patients with type-2-diabetes treated with metformin compared with other hypoglycaemic treatments with no difference in glycemic control between treatments. Non-obese patients with type-2-diabetes are usually treated with insulin-secretagogues or insulin when diet fails. Since non-obese patients with type-2-diabetes also carry a high risk of cardiovascular events, the use of metformin for this sub-group of patients might be more beneficial. Moreover, when insulin-treatment is initiated ongoing oral hypoglycaemic agents (OHA) are often continued, but in non-obese patients with type-2 diabetes little evidence exist for choosing the optimal class of OHA to be combined with insulin. The aim of the project is therefore to investigate the effect of metformin vs. an insulin-secretagogue (repaglinide) in combination with insulin on glycemic control and non-glycemic cardiovascular risk-factors in non-obese patients with type-2-diabetes, uncontrolled on diet alone.
Methodology:
Single-center, double-blind, double-dummy, randomized, parallel study involving 100 non-obese (BMI 27 kg/m2 or lower) patients with type-2-diabetes investigating the effect of treatment with metformin vs. repaglinide each in combination with biphasic insulin (Insulin-aspart 30/70, BIAsp30) for a period of 12 months.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Metformin Drug: Insulin BIAsp30 (Novolog 70/30) Drug: Repaglinide Drug: Placebo-Metformin Drug: Placebo-Repaglinide |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Effect of Repaglinide Versus Metformin Treatment in Combination With Insulin Biasp30 (Novologmix 70/30) Predinner on Glycemic and Non-Glycemic Cardiovascular Risk-Factors in Non-Obese Patients With Type-2-Diabetes With Unsatisfactory Glycaemic Control With Oral Hypoglycaemic Agents |
| Enrollment: | 102 |
| Study Start Date: | January 2003 |
| Study Completion Date: | February 2006 |
| Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
3: Active Comparator
BIAsp30 plus Metformin plus Placebo-Repaglinide. Double-Masked and randomized. Duration: 12 months.
|
Drug: Metformin
Tablets of 500 mg; 1000 mg two times daily.
Drug: Insulin BIAsp30 (Novolog 70/30)
Subcutaneous injection. Starting dose 6 units. Titration according to glycaemic targets during the entire intervention period.
Drug: Placebo-Repaglinide
Tablet corresponding to 1 mg; two tablets three times daily.
|
|
2: Active Comparator
BIAsp30 plus Repaglinide plus Placebo-Metformin. Double-masked and randomized. Duration: 12 months.
|
Drug: Insulin BIAsp30 (Novolog 70/30)
Subcutaneous injection. Starting dose 6 units. Titration according to glycaemic targets during the entire intervention period.
Drug: Repaglinide
Tablets of 1 mg; Dosage: 2 mg three times daily.
Drug: Placebo-Metformin
Tablets corresponding to 500 mg; two tablets two times daily.
|
|
1
Run-in period of four months duration with Repaglinide 6 mg daily plus Metformin 2000 mg daily. No masking of interventions.
|
Drug: Metformin
Tablets of 500 mg; 1000 mg two times daily.
Drug: Repaglinide
Tablets of 1 mg; Dosage: 2 mg three times daily.
|
After four months run-in with repaglinide plus metformin combination-therapy, patients with HemoglobinA1c ≥6.5% will be randomized (baseline=0 month) to repaglinide 2 mg thrice-daily or metformin 1g twice-daily, both in combination with BIAsp30 (30% insulin-aspart; 70% protaminated insulin-aspart) (6U once-daily, pre-dinner) for 12 months.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Study ID Numbers: | Reform |
| Study First Received: | July 1, 2005 |
| Last Updated: | December 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00118963 |
| Health Authority: | Denmark: Danish Medicines Agency |
|
Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Insulin, Asp(B28)- Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin Repaglinide |
|
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
