Effect of Repaglinide Versus Metformin Treatment in Non-O... | NCT00118963

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

NCT00118963

Sponsor

Steno Diabetes Center Copenhagen

Status

Completed

Last Update Posted

Dec 8, 2008Estimated

Enrollment

102Actual

Phase

Phase 4

Conditions

Diabetes Mellitus, Type 2

Interventions

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

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Feb 2006Actual

Completion Date

Feb 2006Actual

First Submitted Date

Jul 1, 2005

First Submission Date that Met QC Criteria

Jul 1, 2005

First Posted Date

Jul 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2008

Last Update Posted Date

Dec 8, 2008Estimated

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Metformin	Drug	Tablets of 500 mg; 1000 mg two times daily.	1 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glycemic control (HbA1c).

Secondary Outcomes

Measure	Description	Time Frame
Hypoglycaemic events
Home monitored plasma-glucose profiles
Insulin-dose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Allan A Vaag, M.D. Chief Physician	Steno Diabetes Center Copenhagen	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Steno Diabetes Center		Gentofte Municipality		2820	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19900993	Derived	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.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals