Effects of metformin in patients with poorly controlled, insulin-treated type 2 diabetes mellitus

A randomized, double-blind, placebo-controlled trial

Larissa Avilés-Santa, Joyce Sinding, Philip Raskin

Research output: Contribution to journalArticle

184 Citations (Scopus)

Abstract

Background: Patients with type 2 diabetes are often obese and require large doses of insulin to achieve glycemic control. Weight gain often accompanies insulin therapy and results in increasing insulin requirements. Objective: To evaluate the efficacy of metformin in combination with insulin in patients with type 2 diabetes poorly controlled with insulin therapy alone. Design: Randomized, double-blind, placebo-controlled trial. Setting: Outpatient diabetes clinic at a university medical center. Patients: 43 patients with poorly controlled type 2 diabetes who were receiving insulin therapy. Intervention: Patients were randomly assigned to receive placebo or metformin in combination with insulin for 24 weeks. Results: Hemoglobin A(1c) levels decreased by 2.5 percentage points (95% Cl, 1.8 to 3.1 percentage points) in the metformin group, a significantly greater change (P = 0.04) than the decrease of 1.6 percentage points in the placebo group. Average final hemoglobin A(1c) levels were 6.5% in the metformin group and 7.6% in the placebo group (difference, 11%). For patients who received placebo, the insulin dose increased 22.8 units (Cl, 11 to 44 units) or 29% more than did the dose for patients who received metformin (P = 0.002); for these patients, the insulin dose decreased slightly. Patients in the placebo group gained an average of 3.2 kg of body weight (Cl, 1.2 to 5.1 kg); patients in the metformin group gained an average of 0.5 kg of body weight (P = 0.07). Total cholesterol and low-density lipoprotein cholesterol levels decreased in both groups. High-density lipoprotein cholesterol and triglyceride levels did not change. Conclusions: The addition of metformin to insulin therapy resulted in hemoglobin A(1c) concentrations that were 10% lower than those achieved by insulin therapy alone. This improvement in glycemic control occurred with the use of 29% less insulin and without significant weight gain. Metformin is an effective adjunct to insulin therapy in patients with type 2 diabetes.

Original languageEnglish (US)
Pages (from-to)182-188
Number of pages7
JournalAnnals of Internal Medicine
Volume131
Issue number3
StatePublished - Aug 3 1999

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Metformin
Type 2 Diabetes Mellitus
Placebos
Insulin
Hemoglobin A
Weight Gain
Therapeutics
Body Weight
Ambulatory Care Facilities
LDL Cholesterol
HDL Cholesterol
Cholesterol

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Effects of metformin in patients with poorly controlled, insulin-treated type 2 diabetes mellitus : A randomized, double-blind, placebo-controlled trial. / Avilés-Santa, Larissa; Sinding, Joyce; Raskin, Philip.

In: Annals of Internal Medicine, Vol. 131, No. 3, 03.08.1999, p. 182-188.

Research output: Contribution to journalArticle

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abstract = "Background: Patients with type 2 diabetes are often obese and require large doses of insulin to achieve glycemic control. Weight gain often accompanies insulin therapy and results in increasing insulin requirements. Objective: To evaluate the efficacy of metformin in combination with insulin in patients with type 2 diabetes poorly controlled with insulin therapy alone. Design: Randomized, double-blind, placebo-controlled trial. Setting: Outpatient diabetes clinic at a university medical center. Patients: 43 patients with poorly controlled type 2 diabetes who were receiving insulin therapy. Intervention: Patients were randomly assigned to receive placebo or metformin in combination with insulin for 24 weeks. Results: Hemoglobin A(1c) levels decreased by 2.5 percentage points (95{\%} Cl, 1.8 to 3.1 percentage points) in the metformin group, a significantly greater change (P = 0.04) than the decrease of 1.6 percentage points in the placebo group. Average final hemoglobin A(1c) levels were 6.5{\%} in the metformin group and 7.6{\%} in the placebo group (difference, 11{\%}). For patients who received placebo, the insulin dose increased 22.8 units (Cl, 11 to 44 units) or 29{\%} more than did the dose for patients who received metformin (P = 0.002); for these patients, the insulin dose decreased slightly. Patients in the placebo group gained an average of 3.2 kg of body weight (Cl, 1.2 to 5.1 kg); patients in the metformin group gained an average of 0.5 kg of body weight (P = 0.07). Total cholesterol and low-density lipoprotein cholesterol levels decreased in both groups. High-density lipoprotein cholesterol and triglyceride levels did not change. Conclusions: The addition of metformin to insulin therapy resulted in hemoglobin A(1c) concentrations that were 10{\%} lower than those achieved by insulin therapy alone. This improvement in glycemic control occurred with the use of 29{\%} less insulin and without significant weight gain. Metformin is an effective adjunct to insulin therapy in patients with type 2 diabetes.",
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