Title
The HOME Trial: Hyperinsulinaemia: the Outcome of Its Metabolic Effects, a Randomized Controlled Trial
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
Phase
Phase 3Lead Sponsor
Bethesda General Hospital, HoogeveenStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Type 2 Diabetes MellitusIntervention/Treatment
sitagliptin ...Study Participants
400The 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.
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 > 7.5%) 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 kg/m2
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 and/or 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: kooy.a@bethesda.nl
Study Official/ Investigators Name: Adriaan Kooy Degree: MD, PhD Officials Role: Study Principal Investigator
Organizational Affiliation:
Bethesda Hospital Hoogeveen Dr. G.H. Amshoffweg 1 7909 AA Hoogeveen The Netherlands
Locations:
Facility: Bethesda Hospital Hoogeveen City: Hoogeveen State/Province: Drenthe Country: The Netherlands Recruitment Status: No longer recruiting (all patients finished)
Facility: Diaconesses' Hospital Meppel City: Meppel State/Province: Drenthe Country: The Netherlands Recruitment Status: No longer recruiting (all patients finished)
Facility: Hospital Coevorden - Hardenberg City: Coevorden State/Province: Drenthe Country: The Netherlands Recruitment Status: No longer recruiting (all patients finished)
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 > 7.5%) 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 kg/m2 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 and/or 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