Insulin Glargine Vs. NPH Combined with Metformin in Type 2 Diabetes

Use of G+MET reduces symptomatic hypoglycemia and dinnertime hyperglycemia compared with NPH+MET, otherwise both provided good control.

For the Lanmet study in type 2 diabetic patients they compared 9 months of combination therapy with insulin glargine and metformin with 9 months of NPH insulin combined with metformin. The primary focus was changes in HbA1c; secondary focus was diurnal glucose profiles and symptomatic hypoglycemia.

In this investigator-initiated open, parallel-group clinical trial involving seven centers, 110 insulin-naive type 2 diabetic patients with poor glycemic control (HbA1c =8.0%) on oral hypoglycemic agents (90% using sulfonylurea plus metformin) were randomized to receive bedtime insulin glargine with metformin (G+MET) or bedtime NPH with metformin (NPH+MET) for 36 weeks. The patients were taught how to self-adjust their insulin dose and use a modem to send the results of home glucose monitoring to treatment centers. The goal was to achieve a fasting plasma glucose (FPG) of 72mg/dL (4.0 mmol/l) to 99mg/dL (5.5 mmol/l) in both groups.

During the last 12 weeks, FPGs averaged 104mg/dL (5.75 mmol/l)and 107mg/dL (5.96 mmol/l) and insulin doses were 68±5 and 70±6 IU/day (0.69±0.05 and 0.66±0.04 IU kg–1 day–1, NS) in the G+MET and NPH+MET groups, respectively. At 36 weeks, mean HbA1c was 7.14±0.12 and 7.16±0.14%, respectively (NS).

Symptomatic, but not confirmed symptomatic, hypoglycemia was significantly lower during the first 12 weeks in the G+MET group (4.1±0.8 episodes/patient-year) than in the NPH+MET group (9.0±2.3 episodes/patient-year, p<0.05), but not significantly different thereafter. Glucose levels before dinner were higher in the NPH+MET group (180mg/dL (10.1±0.3 mmol/l)) than in the G+MET group (155mg/d/L (8.6±0.3 mmol/l, p=0.002)) throughout the 36-week study. With regard to baseline characteristics such as initial glycemia or C-peptide, there was no difference between patients who achieved good glycemic control (HbA1c <7.0%) and those who did not. Differences were seen in the following: between study centers, weight gain during the run-in period and insulin therapy, and FPG during the last 12 weeks (103mg/dL and 5.7±0.2 vs 121mg/dL and6.7±0.3 mmol/l for patients reaching vs those not reaching target, p<0.01).

Good glycemic control can be achieved with both G+MET and NPH+MET. Use of G+MET reduces symptomatic hypoglycemia during the first 12 weeks and dinnertime hyperglycemia compared with NPH+MET.

LANMET study Diabtologia: Issue: Volume 49, Number 3 March 2006, Pages: 442-452.

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FACT:
Energy restriction with low-carbohydrate, high-protein diets favorably affects body mass and composition: The objective of this study by Florida researchers was to determine the effects of variations in protein and carbohydrate intakes on body mass and composition during energy restriction. They found: “After control for energy intake, diets consisting of 35 to 41.4% energy from carbohydrate were associated with a 1.74 kg greater loss of body mass, a 0.69 kg greater loss of fat-free mass, a 1.29% greater loss in percentage body fat, and a 2.05 kg greater loss of fat mass than were diets with a higher percentage of energy from carbohydrate. The researchers concluded: “Low-carbohydrate, high-protein diets favourably affect body mass and composition independent of energy intake, which in part supports the proposed metabolic advantage of these diets.”
American Journal of Clinical Nutrition, Vol. 83, No. 2, 260-274, February 2006.