The Effect of Metformin in Overweight Patients With Dysregulated Type 1 Diabetes Mellitus

NCT00145379 | Completed Phase 4

• 1 other identifier: 006
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Patients suffering from diabetes through many years have a risk of developing late diabetic complications including changes in eyes, kidney, vessels and nerves. Late complications can be postponed or avoided when assuring a good diabetes control, i.e. sensible diet, exercise, frequent blood glucose measurements and a good medical treatment. Blood glucose regulation depends on two different factors i.e. the insulin need of the body and the amount of insulin in the body. The amount of insulin, in blood, is decided by the amount of insulin infused daily, whereas the insulin need depends on the patient's weight, physical activity and diet. Overweight type 2 diabetes patients have a large insulin need and especially this need is decisive for their development of diabetes. If these patients are treated with Metformin, blood glucose decreases and the result is an easier weight loss for the patient. Especially, when these patients take this drug, the development of late diabetic complications, especially arteriosclerosis, can be avoided or postponed. Whether these favourable effects of Metformin are also present in type 1 diabetic patients remains to be fully clarified, but some studies have indicated that this is the case. This results in a better regulation of diabetes on a smaller insulin dose than the one given to the patients before. Metformin probably takes effect by increasing the glucose uptake in muscles and by reducing the hepatic glucose production. The drug usually has no side-effects, but some patients do, however, suffer from abdominal pain, small tendency to nausea, loose defaecation and a metallic taste in the mouth. These side-effects are often temporary. Project description In total, 50 type 1 diabetic patients are offered to participate in the project. All are from the outpatient clinic at the Department of Endocrinology. The project lasts 7 months divided as follows:

1. 1.An introductory period of one month introducing an optimisation of the insulin treatment
2. 2.A 6 month period (in which neither the patients nor the treating doctor know which medication is given) with either T. Metformin treatment twice daily or T. Placebo (lime) twice daily together with the usual insulin treatment four times daily.

Conditions

Type 1 Diabetes Mellitus

Keywords

type 1 diabetes mellitus; insulin resistance; metformin; randomized, controlled study

Outcome Measures

Primary Outcomes (1)

• HbA1c after the two intervention periods

Secondary Outcomes (1)

• Insulin need, hypoglycaemia frequence, body weight, lipid profile, blood pressure after the two intervention periods

Study Arms (2)

Metformin

EXPERIMENTAL

Drug: Tablet Metformin 500 mg

Placebo comparator

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Tablet Metformin 500 mg DRUG

Metformin

Placebo DRUG

Placebo comparator

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with type 1 diabetes mellitus treated with insulin 4 times daily.
• Age: 18-60 years
• Fertile women use adequate contraception, e.g. contraceptive pills
• C-peptide \<300 pmol/L
• BMI \>/= 25
• HbA1c \>/=8%

You may not qualify if:

• Pregnant and patients planning to become pregnant during the investigation period
• Reduced eyesight
• Known kidney disease, s-creatinin \>100
• Liver disease, Alat \> 50
• Neuropathic patients diagnosed by clinical examination

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Diabetes Research Center

Odense, Funen, 5000, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Study Officials

• Iben Brock Jacobsen, MD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 5, 2005
• Study Start: March 1, 2003
• Study Completion: June 1, 2006
• Last Updated: May 20, 2013

Record last verified: 2013-05

Locations

DK (1)