The HOME Trial: Hyperinsulinaemia: the Outcome of Its Metabolic Effects, a Randomized Controlled Trial - Full Text View

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus	Drug: Metformin on top of intensive insulin therapy	Phase 3

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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 > 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)

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	400 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
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
Study Start Date :	January 1998
Study Completion Date :	October 2002

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Type 2 diabetes

Drug Information available for: Metformin Metformin hydrochloride Insulin

U.S. FDA Resources

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:	30 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00375388

Locations

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Netherlands
Bethesda General Hospital and Bethesda Diabetes Center
Hoogeveen, Drenthe, Netherlands, 7909 AA

Sponsors and Collaborators

Bethesda General Hospital, Hoogeveen

Takeda

LifeScan

Merck KGaA, Darmstadt, Germany

Dupont Merck

Merck Sharp & Dohme LLC

Novo Nordisk A/S

Investigators

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Principal Investigator:	Adriaan Kooy, MD, PhD	Bethesda General Hospital and Bethesda Diabetes Center, Hoogeveen, The Netherlands (for address: see above)
Study Director:	Coen Stehouwer, MD, PhD	University Hospital of Maastricht, The Netherlands

More Information

Publications of Results:

Wulffele MG, Kooy A, Lehert P, Bets D, Ogterop JC, Borger van der Burg B, Donker AJ, Stehouwer CD. Combination of insulin and metformin in the treatment of type 2 diabetes. Diabetes Care. 2002 Dec;25(12):2133-40. doi: 10.2337/diacare.25.12.2133.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Stultiens JMG, Top WMC, Kimenai DM, Lehert P, Bekers O, Stehouwer CDA, Kooy A, Meex SJR. Metformin and high-sensitivity cardiac troponin I and T trajectories in type 2 diabetes patients: a post-hoc analysis of a randomized controlled trial. Cardiovasc Diabetol. 2022 Apr 4;21(1):49. doi: 10.1186/s12933-022-01482-z.

Out M, Becker ML, van Schaik RH, Lehert P, Stehouwer CD, Kooy A. A gene variant near ATM affects the response to metformin and metformin plasma levels: a post hoc analysis of an RCT. Pharmacogenomics. 2018 Jun 1;19(8):715-726. doi: 10.2217/pgs-2018-0010. Epub 2018 May 23.

Out M, Top WMC, Lehert P, Schalkwijk CA, Stehouwer CDA, Kooy A. Long-term treatment with metformin in type 2 diabetes and vitamin D levels: A post-hoc analysis of a randomized placebo-controlled trial. Diabetes Obes Metab. 2018 Aug;20(8):1951-1956. doi: 10.1111/dom.13327. Epub 2018 May 14.

Out M, Kooy A, Lehert P, Schalkwijk CA, Stehouwer CDA. Long-term treatment with metformin in type 2 diabetes and methylmalonic acid: Post hoc analysis of a randomized controlled 4.3year trial. J Diabetes Complications. 2018 Feb;32(2):171-178. doi: 10.1016/j.jdiacomp.2017.11.001. Epub 2017 Nov 8.

Out M, Miedema I, Jager-Wittenaar H, van der Schans C, Krijnen W, Lehert P, Stehouwer C, Kooy A. Metformin-associated prevention of weight gain in insulin-treated type 2 diabetic patients cannot be explained by decreased energy intake: A post hoc analysis of a randomized placebo-controlled 4.3-year trial. Diabetes Obes Metab. 2018 Jan;20(1):219-223. doi: 10.1111/dom.13054. Epub 2017 Sep 14.

de Jager J, Kooy A, Lehert P, Wulffele MG, van der Kolk J, Bets D, Verburg J, Donker AJ, Stehouwer CD. Long term treatment with metformin in patients with type 2 diabetes and risk of vitamin B-12 deficiency: randomised placebo controlled trial. BMJ. 2010 May 20;340:c2181. doi: 10.1136/bmj.c2181.

Kooy A, de Jager J, Lehert P, Bets D, Wulffele MG, Donker AJ, Stehouwer CD. Long-term effects of metformin on metabolism and microvascular and macrovascular disease in patients with type 2 diabetes mellitus. Arch Intern Med. 2009 Mar 23;169(6):616-25. doi: 10.1001/archinternmed.2009.20.

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ClinicalTrials.gov Identifier:	NCT00375388
Other Study ID Numbers:	MET/NL/97.01
First Posted:	September 13, 2006 Key Record Dates
Last Update Posted:	September 13, 2006
Last Verified:	September 2006

Keywords provided by Bethesda General Hospital, Hoogeveen:


Type 2 diabetes mellitus Metformin on top of insulin therapy Randomized placebo-controlled trial Diabetes regulation Daily dose of insulin Body Weight Patients with type 2 diabetes Intensive insulin therapy Age: 30-80 years	Body mass index Lipids Blood Pressure Endothelial function Low grade inflammation Fibrinolysis Microvascular complications Macrovascular complications

Additional relevant MeSH terms:

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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases	Endocrine System Diseases Metformin Hypoglycemic Agents Physiological Effects of Drugs