Effect of Repaglinide Versus Metformin Treatment in Non-Obese Patients With Type-2-Diabetes
NCT ID: NCT00118963
Last Updated: 2008-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
102 participants
INTERVENTIONAL
2003-01-31
2006-02-28
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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3
BIAsp30 plus Metformin plus Placebo-Repaglinide. Double-Masked and randomized. Duration: 12 months.
Metformin
Tablets of 500 mg; 1000 mg two times daily.
Insulin BIAsp30 (Novolog 70/30)
Subcutaneous injection. Starting dose 6 units. Titration according to glycaemic targets during the entire intervention period.
Placebo-Repaglinide
Tablet corresponding to 1 mg; two tablets three times daily.
2
BIAsp30 plus Repaglinide plus Placebo-Metformin. Double-masked and randomized. Duration: 12 months.
Insulin BIAsp30 (Novolog 70/30)
Subcutaneous injection. Starting dose 6 units. Titration according to glycaemic targets during the entire intervention period.
Repaglinide
Tablets of 1 mg; Dosage: 2 mg three times daily.
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.
Metformin
Tablets of 500 mg; 1000 mg two times daily.
Repaglinide
Tablets of 1 mg; Dosage: 2 mg three times daily.
Interventions
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Metformin
Tablets of 500 mg; 1000 mg two times daily.
Insulin BIAsp30 (Novolog 70/30)
Subcutaneous injection. Starting dose 6 units. Titration according to glycaemic targets during the entire intervention period.
Repaglinide
Tablets of 1 mg; Dosage: 2 mg three times daily.
Placebo-Metformin
Tablets corresponding to 500 mg; two tablets two times daily.
Placebo-Repaglinide
Tablet corresponding to 1 mg; two tablets three times daily.
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes
* Age 40 years or older
* HbA1c = 6.5% or higher at baseline.
Exclusion Criteria
* Pregnancy
* Other serious physical or mental illnesses with a life-shortening prognosis.
* Drug or alcohol abuse.
* Weight-loss of more than 5 kg during the last 6 month prior to enrollment.
40 Years
ALL
No
Sponsors
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Steno Diabetes Center Copenhagen
OTHER
Principal Investigators
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Allan A Vaag, M.D. Chief Physician
Role: STUDY_CHAIR
Steno Diabetes Center Copenhagen
Locations
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Steno Diabetes Center
Gentofte Municipality, , Denmark
Countries
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References
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Lund SS, Tarnow L, Frandsen M, Nielsen BB, Hansen BV, Pedersen O, Parving HH, Vaag AA. Combining insulin with metformin or an insulin secretagogue in non-obese patients with type 2 diabetes: 12 month, randomised, double blind trial. BMJ. 2009 Nov 9;339:b4324. doi: 10.1136/bmj.b4324.
Other Identifiers
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Reform
Identifier Type: -
Identifier Source: org_study_id