Insulin glargine compared to NPH among insulin-naïve, U.S. inner city, ethnic minority type 2 diabetic patients

Diabetes Res Clin Pract. 2011 Mar;91(3):293-9. doi: 10.1016/j.diabres.2010.11.028. Epub 2010 Dec 13.

Abstract

Aims: We compared basal regimens of glargine or NPH among insulin-naïve, U.S. inner city, ethnic minority type 2 diabetic patients who were sub-optimally controlled on maximally tolerated doses of combination oral agents.

Methods: Eighty-five subjects were randomized to 26 weeks of open-label, add-on therapy using single doses of bedtime NPH, bedtime glargine, or morning glargine; initially through an 8-week dose titration phase, followed by a 16-week maintenance phase during which insulin doses were adjusted only to avoid symptomatic hypoglycemia.

Results: All three groups were comparable at baseline (mean HbA(1c) 9.3 ± 1.4%), and improved their HbA(1c) (to 7.8 ± 1.3%), fasting, and pre-supper glucose readings, with no significant between-group differences. Weight gain was greater with either glargine regimen (+3.1 ± 4.1 kg and +1.7 ± 4.2 kg) compared to NPH (-0.2 ± 3.9 kg), despite comparable total insulin doses. Pre-supper hypoglycemia occurred more frequently with morning glargine, but nocturnal hypoglycemia and improvements in treatment satisfaction did not differ among groups.

Conclusions: Among inner city ethnic minority type 2 diabetic patients in the U.S., we found no differences in basal glycemic control or nocturnal hypoglycemia between glargine and NPH, although glargine precipitated greater weight gain.

Trial registration: ClinicalTrials.gov NCT00686712.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Blood Glucose / drug effects
  • Circadian Rhythm
  • Cities
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / ethnology*
  • Ethnic Groups
  • Glycated Hemoglobin A / drug effects
  • Humans
  • Hypoglycemic Agents / therapeutic use
  • Insulin / administration & dosage
  • Insulin / analogs & derivatives*
  • Insulin Glargine
  • Insulin, Isophane / administration & dosage*
  • Insulin, Long-Acting
  • Maximum Tolerated Dose
  • Middle Aged
  • Minority Groups
  • Treatment Outcome
  • Weight Gain / drug effects
  • Young Adult

Substances

  • Blood Glucose
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Insulin
  • Insulin, Long-Acting
  • Insulin Glargine
  • Insulin, Isophane

Associated data

  • ClinicalTrials.gov/NCT00686712