Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00375388
Status:
COMPLETED
Last Update Posted:
2006-09-13
First Post:
2006-09-12
Brief Title:
The HOME Trial Hyperinsulinaemia the Outcome of Its Metabolic Effects a Randomized Controlled Trial
Sponsor:
Bethesda General Hospital Hoogeveen
Organization:
Bethesda General Hospital Hoogeveen
Study Overview
Official Title:
Study of Metformin HCL in Patients With Type 2 Diabetes Intensively Treated With Insulin a Treatment Strategy for Insulin Resistance in Type 2 Diabetes Mellitus a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2006-09
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:
The HOME-trial is a prospective randomized controlled trial The purpose of this study is to investigate the effects of metformin HCL in patients with type 2 diabetes mellitus intensively treated with insulin on the quality of the metabolic control of diabetes the daily dose of insulin the lipid profile the blood pressure the incidence progression of microvascular and macrovascular complications and on the qualify of life Diabetes Health Profile Early results had been published in Diabetes Care December 2002 pages 2133-2140
Detailed Description:
The HOME-trial is a prospective randomized controlled trial The purpose of this study is to investigate the effects of metformin HCL in patients with type 2 diabetes mellitus intensively treated with insulin on the quality of the metabolic control of diabetes the daily dose of insulin the lipid profile the blood pressure the incidence progression of microvascular and macrovascular complications and on the qualify of life Diabetes Health Profile Early results had been published in Diabetes Care December 2002 pages 2133-2140
Phase Phase III
Study Type Interventional
Overall Status No longer recruiting all patients have finished the study
Study Start Date 02 January 1998
Study Completion Date October 2002
Study Design
Study Purpose Treatment Allocation 1 randomized 0 non randomized Masking Double blind Control Placebo Assignment Parallel Endpoints Safety Efficacy
Primary Outcome
To investigate the quality of the metabolic control of diabetes and related variables daily dose of insulin body weight
Secondary Outcome
To investigate the occurrence of macro- and microvascular complications
To investigate the quality of life and to perform a socio-economic evaluation
Conditions
Type 2 diabetes mellitus requiring insulin therapy
Keywords
Type 2 diabetes mellitus metformin randomized double-blind placebo-controlled diabetes regulation
Interventions Metformin 850 mg or placebo 1-3 times daily
Insulin 4 times daily or mixtures of 30 rapidly and 70 slowly acting insulin 2 times daily
Eligibility Criteria only add main ones
Inclusion Criteria
Patients of both sexes women after menopause women of child-bearing age after sterilization or if practicing reliable contraception
Type 2 DM requiring insulin therapy after failure of maximal oral antidiabetic treatment glycosylated Hb 75 and need for exogenous insulin No concomitant use of oral antidiabetic agents
Being ambulatory
Age 30 to 80 years
Proven absence of Islet Antibodies if QI 28 kgm2
Insulin therapy 4 times daily 21 or insulin therapy 2 times daily using insulin mixtures rapidly and slowly acting
Standard dietary prescription by the dietician
Absence of keto-acidosis
Informed consent
Exclusion Criteria
Congestive heart failure NYHA-classes III or IV
Cardiac failure andor myocardial infarction in the last four months before enrolment
Other severe organic systemic disease
Metformin-induced lactic-acidosis
Intolerance to metformin hydrochloride
Renal disease or renal dysfunction
Hypoxic states
Severe hepatic dysfunction
Excessive alcohol intake acute or chronic
Acute or chronic metabolic acidosis
Gender Both
Age 30 - 80 years
Target Number of Subjects 400 200 metformin 200 placebo
Central Contact
Name Adriaan Kooy internist - diabetologist Degree MD PhD Phone 0528-286222 Extension 624 Mail kooyabethesdanl
Study Official Investigators Name Adriaan Kooy Degree MD PhD Officials Role Study Principal Investigator
Organizational Affiliation
Bethesda Hospital Hoogeveen Dr GH Amshoffweg 1 7909 AA Hoogeveen The Netherlands
Locations
Facility Bethesda Hospital Hoogeveen City Hoogeveen StateProvince Drenthe Country The Netherlands Recruitment Status No longer recruiting all patients finished
Facility Diaconesses Hospital Meppel City Meppel StateProvince Drenthe Country The Netherlands Recruitment Status No longer recruiting all patients finished
Facility Hospital Coevorden - Hardenberg City Coevorden StateProvince Drenthe Country The Netherlands Recruitment Status No longer recruiting all patients finished
Phase Phase III
Study Type Interventional
Overall Status No longer recruiting all patients have finished the study
Study Start Date 02 January 1998
Study Completion Date October 2002
Study Design
Study Purpose Treatment Allocation 1 randomized 0 non randomized Masking Double blind Control Placebo Assignment Parallel Endpoints Safety Efficacy
Primary Outcome
To investigate the quality of the metabolic control of diabetes and related variables daily dose of insulin body weight
Secondary Outcome
To investigate the occurrence of macro- and microvascular complications
To investigate the quality of life and to perform a socio-economic evaluation
Conditions
Type 2 diabetes mellitus requiring insulin therapy
Keywords
Type 2 diabetes mellitus metformin randomized double-blind placebo-controlled diabetes regulation
Interventions Metformin 850 mg or placebo 1-3 times daily
Insulin 4 times daily or mixtures of 30 rapidly and 70 slowly acting insulin 2 times daily
Eligibility Criteria only add main ones
Inclusion Criteria
Patients of both sexes women after menopause women of child-bearing age after sterilization or if practicing reliable contraception
Type 2 DM requiring insulin therapy after failure of maximal oral antidiabetic treatment glycosylated Hb 75 and need for exogenous insulin No concomitant use of oral antidiabetic agents
Being ambulatory
Age 30 to 80 years
Proven absence of Islet Antibodies if QI 28 kgm2
Insulin therapy 4 times daily 21 or insulin therapy 2 times daily using insulin mixtures rapidly and slowly acting
Standard dietary prescription by the dietician
Absence of keto-acidosis
Informed consent
Exclusion Criteria
Congestive heart failure NYHA-classes III or IV
Cardiac failure andor myocardial infarction in the last four months before enrolment
Other severe organic systemic disease
Metformin-induced lactic-acidosis
Intolerance to metformin hydrochloride
Renal disease or renal dysfunction
Hypoxic states
Severe hepatic dysfunction
Excessive alcohol intake acute or chronic
Acute or chronic metabolic acidosis
Gender Both
Age 30 - 80 years
Target Number of Subjects 400 200 metformin 200 placebo
Central Contact
Name Adriaan Kooy internist - diabetologist Degree MD PhD Phone 0528-286222 Extension 624 Mail kooyabethesdanl
Study Official Investigators Name Adriaan Kooy Degree MD PhD Officials Role Study Principal Investigator
Organizational Affiliation
Bethesda Hospital Hoogeveen Dr GH Amshoffweg 1 7909 AA Hoogeveen The Netherlands
Locations
Facility Bethesda Hospital Hoogeveen City Hoogeveen StateProvince Drenthe Country The Netherlands Recruitment Status No longer recruiting all patients finished
Facility Diaconesses Hospital Meppel City Meppel StateProvince Drenthe Country The Netherlands Recruitment Status No longer recruiting all patients finished
Facility Hospital Coevorden - Hardenberg City Coevorden StateProvince Drenthe Country The Netherlands Recruitment Status No longer recruiting all patients finished
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