Insulin Glargine at Bedtime or in AM Versus NPH

Type 2 Diabetes Mellitus Clinical Trial

Official title:

The Utility of Insulin Glargine (Lantus) Compared to NPH in Ethnic Minority Type 2 Diabetic Subjects Starting Insulin Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00686712
• Other study ID #: 03-02-524
• Secondary ID: U54RR014616
• Status: Completed
• Phase: Phase 4
• First received: May 27, 2008
• Last updated: March 25, 2013
• Start date: February 2003
• Est. completion date: August 2009

Study information

• Verified date: March 2013
• Source: Charles Drew University of Medicine and Science
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To compare the efficacy and safety of once-nightly insulin glargine versus a single morning injection of glargine or once-nightly NPH insulin in ethnic minority type 2 diabetic patients inadequately controlled on combination oral agents.

Description:

Insulin glargine has a longer action than compared to NPH insulin, but whether this results in improved control when used as a once-nightly or morning basal insulin injection in type 2 diabetic patients who are inadequately controlled on combination oral agents has been controversial. Inner city ethnic minority patients with diabetes are a particularly challenging population of diabetic patients to treat. This study investigates whether insulin glargine may be a more effective or safer first-line basal insulin than NPH in this population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female, age 18-75

• Type 2 diabetes diagnosed for at least 1 year

• Treatment with stable doses of oral agents (alone or in combination) for at least 2 months

• Inadequate glycemic control (hemoglobin A1c = 7.5%) on maximum-tolerated doses of a sulfonylurea, metformin and a thiazolidinedione

• No past history of chronic insulin use (other than treatment of gestational diabetes or hospitalizations of less than 1 week in duration)

• Hemoglobin A1c between 7.5% and 12%

• Body mass index (BMI) between 20 and 40 kg/m2

Exclusion Criteria:

• Current or previous chronic use of insulin (other than for treatment of gestational diabetes)

• History of confirmed (or clinical suspicion of) type 1 diabetes

• Female subjects of childbearing potential who are sexually active and not using a reliable form of contraception

• Current pregnancy or lactation.

• Subjects for whom insulin therapy is contraindicated or for whom, in the opinion of the investigator, therapy with insulin is not indicated

• Subjects with advanced proliferative diabetic retinopathy

• Subjects who work night shifts or who are unable to stay on a consistent daily meal schedule

• History of any clinically significant renal, hepatic, cardiovascular, neurological, endocrinological or other major systemic disease that, in the opinion of the investigator, may make implementation of the protocol or interpretation of the data difficult.

• Subjects who will likely require or initiate therapy with drugs which may interfere with glucose metabolism during the course of the study

• Subjects who are in another investigational study or have received another investigational medication within 30 days of study entry

• Subjects who are unable or unwilling to comply with all components of the study protocol, including contacting the investigators at specified times and attending all scheduled follow-up visits.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Insulin glargine
Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)
• Insulin glargine
Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)
• NPH insulin
NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)

Locations

Country	Name	City	State
United States	Charles Drew University of Medicine and Science	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Charles Drew University of Medicine and Science	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c Change From Baseline		Baseline to 6 months	No
Secondary	Frequency of Glucose Readings < 130 mg/dL		6 months	No
Secondary	Frequency of Total Hypoglycemic Reactions		6 months	Yes
Secondary	Frequency of Severe Hypoglycemic Reactions		6 months	Yes
Secondary	Body Mass Index Change From Baseline		6 months	No
Secondary	Total Daily Insulin Dose		6 months	No
Secondary	Any Adverse Event Other Than Hypoglycemia		6 months	Yes