Effect of Repaglinide Versus Metformin Treatment in Non-Obese Patients With Type-2-Diabetes

NCT00118963 | Completed Phase 4

• 1 other identifier: Reform
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Glycemic control (HbA1c).

Secondary Outcomes (7)

• Hypoglycaemic events

• Home monitored plasma-glucose profiles

• Insulin-dose

• Non-glycemic cardiovascular risk factors: 24h blood-pressure measurement

• 24h urinary albumin excretion-rate.

Study Arms (3)

3

ACTIVE COMPARATOR

BIAsp30 plus Metformin plus Placebo-Repaglinide. Double-Masked and randomized. Duration: 12 months.

Drug: Metformin; Drug: Insulin BIAsp30 (Novolog 70/30); Drug: Placebo-Repaglinide

2

ACTIVE COMPARATOR

BIAsp30 plus Repaglinide plus Placebo-Metformin. Double-masked and randomized. Duration: 12 months.

Drug: Insulin BIAsp30 (Novolog 70/30); Drug: Repaglinide; Drug: Placebo-Metformin

1

OTHER

Run-in period of four months duration with Repaglinide 6 mg daily plus Metformin 2000 mg daily. No masking of interventions.

Drug: Metformin; Drug: Repaglinide

Interventions

Metformin DRUG

Tablets of 500 mg; 1000 mg two times daily.

1; 3

Insulin BIAsp30 (Novolog 70/30) DRUG

Subcutaneous injection. Starting dose 6 units. Titration according to glycaemic targets during the entire intervention period.

2; 3

Repaglinide DRUG

Tablets of 1 mg; Dosage: 2 mg three times daily.

1; 2

Placebo-Metformin DRUG

Tablets corresponding to 500 mg; two tablets two times daily.

2

Placebo-Repaglinide DRUG

Tablet corresponding to 1 mg; two tablets three times daily.

3

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-obese patients (BMI \< 27 kg/m2)
• Type 2 diabetes
• Age 40 years or older
• HbA1c = 6.5% or higher at baseline.

You may not qualify if:

• No known contraindications for either of the study-drugs (known allergy to the study-drugs; heart-, liver- or kidney-failure)
• 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.

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead

Study Sites (1)

Steno Diabetes Center

Gentofte Municipality, 2820, Denmark

Location

Related Publications (1)

• 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.

  PMID: 19900993 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; repaglinide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Allan A Vaag, M.D. Chief Physician

  Steno Diabetes Center Copenhagen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2005
• First Posted: July 12, 2005
• Study Start: January 1, 2003
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: December 8, 2008

Record last verified: 2008-12

Locations

DK (1)