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Completed

NCT Number: NCT00118937

Effect of Metformin in Patients With Type-1 Diabetes With Inadequate Glycaemic Control by Insulin and Diet

Ninety percent of patients with type-1-diabetes will develop late-diabetic complications in the eyes, kidneys, nervous- or cardiovascular-system. Poor glycaemic control is an important risk-factor for development of these late-diabetic complications. The Diabetes Control and Complications Trial (DCCT)-study showed, that improved glycaemic control can prevent the development and progression of these late-diabetic complications. Until now treatment with insulin- and diet-therapy has been the only treatment-modalities available to improve the glycaemic control in patients with type-1-diabetes. A substantial number of these patients still have long-standing poor glycaemic control despite intensive treatment with insulin- and diet-therapy.

The antidiabetic drug metformin has shown to be able to improve the glycaemic control in combination with insulin and furthermore reduce both mortality and the risk of developing cardiovascular disease in patients with type-2-diabetes.

Only few small studies have investigated the effect of treatment with metformin in patients with type-1-diabetes. These studies have suggested a positive effect of metformin in these patients too.

Method:

100 patients with type-1-diabetes with persistent poor glycaemic control i.e. HbA1c > 8.5% during the last 12 months are eligible. Patients are treated for one month with placebo. Hereafter half of the patients will be treated with metformin and the other half continues with placebo for 12 months both as add-on therapy. All patients are continuing ongoing treatment with insulin throughout the study. Before and after the start of treatment with metformin the effect on glycaemic control and other known risk-factors for development of cardiovascular disease i. e. blood-pressure, fasting lipids, urine-albumine-excretion, endothelial dysfunction, inflammation, fibrinolysis etc. is assessed.

This study will show if treatment with metformin can improve the glycaemic control and hereby the prognosis of patients with type-1-diabetes with persistent poor glycaemic control despite intensive treatment with insulin- and diet-therapy. This group of patients suffers the highest risk of developing late-diabetic complications with reduced quality of life and life-expectancy as a consequence.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HbA1c > 8.5% for more than one year prior to enrolment.
  • Diabetes-duration > 5 years.
  • Age at onset of diabetes < 35 years
  • Fasting C-peptide < 300 pmol/l
  • Age > 18 years at enrolment.

Exclusion criteria

  • Clinical or biochemical signs of kidney-, liver- or heart-failure.
  • Other coexisting serious morbidity, which will affect the study-participation or outcome of the study i.e. cancer.
  • Known abuse of any medication or alcohol
  • Hypoglycaemia unawareness.
  • Pregnancy or planned pregnancy in the study-period.

Treatment and study plan

metformin

Drug

Tablet Metformin 500 mg, Dosage: 1000 mg two times daily (2000 mg total daily dose).

Placebo.

Drug

Tablet Placebo (corresponding to 500 mg metformin). Dosage: 1 tablet per day.

Primary outcomes

  1. HbA1c - difference between final visit and baseline.

Secondary outcomes

  1. Absolute HbA1c

  2. Number of mild and severe hypoglycaemia with or without measurements of blood-glucose.

  3. Insulin-dose

  4. The following parameters are measured at baseline and at the final visit after 12 months of intervention:

  5. Plasma-PAI-antigen and -activity, t-PA-antigen- and activity.

  6. Plasma-fibrinogen

  7. Serum-albumin

  8. Markers of endothelial dysfunction: Von Willebrand Factor, ICAM, VCAM, Amadori-protein, selectin and endothelin.

  9. Plasma-homocysteine

  10. Asymmetric DiMethylArginine - ADMA

  11. Urine-albumin-excretion in three 24 hour urine-collections

  12. Blood-pressure in the sitting position after 10 minutes of rest.

  13. Fasting lipid-profile (total-cholesterol, LDL-cholesterol, HDL-cholesterol, VLDL-cholesterol and triglycerides), small-dense-LDL, Lp(a) and Apo-B100.

  14. Weight, BMI and Waist-hip-ratio

  15. White blood-cell-count, hs-CRP, Interleukin-6 and TNF-alfa.

  16. Serum-creatinine, sodium, potassium, ASAT, alkaline phosphatase, Factor 2, 7, 10, Cobalamin, Erythrocyte-folate and Haemoglobin-concentration.

  17. Extra blood- and urine-samples will be stored at -80 degrees Celsius for potential extra analyses after closure of the study. DNA will be stored for later pharmaco-genetic analysis.

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Registry information

Official study title

Effect of Metformin On Glycaemic Control and Non-Glycaemic Cardiovascular Risk-Factors in Patients With Type-1 Diabetes, With Long-Standing Inadequate Glycaemic Control by Insulin and Diet

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Jul 12, 2005
Registry last updated
Dec 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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