Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118963
Status:
COMPLETED
Last Update Posted:
2008-12-08
First Post:
2005-07-01
Brief Title:
Effect of Repaglinide Versus Metformin Treatment in Non-Obese Patients With Type-2-Diabetes
Sponsor:
Steno Diabetes Center Copenhagen
Organization:
Steno Diabetes Center Copenhagen
Study Overview
Official Title:
Effect of Repaglinide Versus Metformin Treatment in Combination With Insulin Biasp30 Novologmix 7030 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:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 kgm2 or lower patients with type-2-diabetes investigating the effect of treatment with metformin vs repaglinide each in combination with biphasic insulin Insulin-aspart 3070 BIAsp30 for a period of 12 months
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 kgm2 or lower patients with type-2-diabetes investigating the effect of treatment with metformin vs repaglinide each in combination with biphasic insulin Insulin-aspart 3070 BIAsp30 for a period of 12 months
Detailed Description:
After four months run-in with repaglinide plus metformin combination-therapy patients with HemoglobinA1c 65 will be randomized baseline0 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None