Insulin Glargine Versus Twice-Daily 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 on Combination Insulin-Oral Agent Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00687453
• Other study ID #: 03-02-519
• Secondary ID: U54RR014616
• Status: Terminated
• Phase: Phase 4
• Start date: February 2003
• Est. completion date: August 2009

Study information

• Verified date: October 2023
• Source: Charles Drew University of Medicine and Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the efficacy and safety of once-nightly insulin glargine versus twice-daily NPH insulin in ethnic minority type 2 diabetic patients inadequately treated with once-nightly NPH insulin alone.

Description:

Insulin glargine has a longer action than compared to NPH insulin, but whether this results in improved control when compared to twice-daily NPH insulin is not known when used in low-income ethnic minority patients. This study investigates whether insulin glargine may be more or less effective and safe than twice-daily NPH insulin in this population.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• 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

• Inadequate glycemic control (hemoglobin A1c = 7.5%) on stable and maximum-tolerated doses of a sulfonylurea, metformin and a thiazolidinedione, plus a single bedtime injection of NPH insulin

• Except for the subject's current bedtime NPH insulin, no other past history of chronic insulin use (other than treatment of gestational diabetes or hospitalizations of less than 1 week in duration)

• Average fasting plasma glucose level <130 mg/dL without fasting hypoglycemia

• Hemoglobin A1c between 7.5% and 12%

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

Exclusion Criteria:

• 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 intensive insulin therapy is contraindicated

• Subjects with advanced proliferative diabetic retinopathy

• Subjects 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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Insulin glargine at bedtime instead of NPH
Insulin glargine at bedtime substituting for NPH insulin at bedtime
• NPH twice-daily
Addition of morning NPH to bedtime NPH

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
Secondary	Frequency of Pre-supper Glucose Readings 130 mg/dL or Less, Change From Baseline		6 months
Secondary	Frequency of Total Hypoglycemic Reactions		6 months
Secondary	Frequency of Severe Hypoglycemic Reactions		6 months
Secondary	Body Mass Index Change From Baseline		Baseline and 6 months
Secondary	Total Daily Insulin Dose		Baseline and 6 months
Secondary	Any Adverse Event Other Than Hypoglycemia		6 months