A Randomized Trial of Adding Insulin Glargine vs. Avoidance of Insulin in People With Type 2 Diabetes on Either No Oral Glucose-Lowering Agents or Submaximal Doses of Metformin and/or Sulphonylureas. The Canadian INSIGHT (Implementing New Strategies With Insulin Glargine for Hyperglycaemia Treatment) Study

Diabet Med. 2006 Jul;23(7):736-42. doi: 10.1111/j.1464-5491.2006.01881.x.

Abstract

Aims: Insulin is generally withheld until people with Type 2 diabetes are unresponsive to other therapies. However, its potential advantages suggest that it could be added earlier to achieve glycaemic goals; this possibility was tested in a clinical trial.

Methods: Consenting adults aged 18-80 years with Type 2 diabetes for at least 6 months, HbA1c of 7.5-11%, and on 0, 1 or 2 oral agents, were randomized to one of two therapeutic approaches for 24 weeks: evening insulin glargine plus self-titration by 1 unit/day if the fasting plasma glucose (FPG) was > 5.5 mmol/l; or conventional therapy with physician adjustment of oral glucose-lowering agents if capillary FPG levels were > 5.5 mmol/l. The primary outcome was the first achievement of two consecutive HbA1c levels <or= 6.5%.

Results: Two hundred and six participants were allocated to glargine and 199 to oral agents. Compared with control subjects, participants receiving glargine: (i) were 1.68 times more likely to achieve two consecutive HbA1c levels <or= 6.5% (95% CI 1.00-2.83; P = 0.049); (ii) reduced their HbA1c by 1.55 vs. 1.25% (P = 0.005), achieving adjusted means of 7.0 vs. 7.2% (P = 0.0007); (iii) had lower FPG (P = 0.0001), non-high-density lipoprotein (HDL) cholesterol (P = 0.02) and triglycerides (P = 0.02); (iv) had greater increases in treatment satisfaction (P = 0.045); and (v) had a 1.9-kg greater increase in weight (P < 0.0001). No differences in hypoglycaemia were noted.

Conclusions: Adding insulin glargine is more likely to achieve a lower HbA(1c) level than conventional therapy with oral agents.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Blood Glucose / analysis
  • Canada
  • Diabetes Mellitus, Type 2 / complications
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Drug Therapy, Combination
  • Female
  • Glycated Hemoglobin A / metabolism*
  • Humans
  • Hypoglycemia / complications
  • Hypoglycemic Agents / therapeutic use*
  • Insulin / administration & dosage
  • Insulin / analogs & derivatives*
  • Insulin Glargine
  • Insulin, Long-Acting
  • Male
  • Metformin / therapeutic use*
  • Middle Aged
  • Sulfonylurea Compounds / therapeutic use*
  • Treatment Outcome

Substances

  • Blood Glucose
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Insulin
  • Insulin, Long-Acting
  • Sulfonylurea Compounds
  • Insulin Glargine
  • Metformin