Insulin Glargine Versus Twice-Daily NPH

NCT ID: NCT00687453

Last Updated: 2023-11-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2009-08-31

Brief 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.

Detailed 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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin glargine injected at bedtime

Insulin glargine injected at bedtime

Group Type: EXPERIMENTAL

Insulin glargine at bedtime instead of NPH

Intervention Type: DRUG

Insulin glargine at bedtime substituting for NPH insulin at bedtime

NPH insulin injected twice-daily

NPH insulin injected twice-daily, before breakfast and at bedtime

Group Type: ACTIVE_COMPARATOR

NPH twice-daily

Intervention Type: DRUG

Addition of morning NPH to bedtime NPH

Interventions

Insulin glargine at bedtime instead of NPH

Insulin glargine at bedtime substituting for NPH insulin at bedtime

Intervention Type: DRUG

NPH twice-daily

Addition of morning NPH to bedtime NPH

Intervention Type: DRUG

Other Intervention Names

Trade name: Lantus; (Generic)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Research Resources (NCRR)

NIH

Sponsor Role: collaborator

Charles Drew University of Medicine and Science

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stanley Hsia, MD

Role: PRINCIPAL_INVESTIGATOR

Charles Drew University of Medicine and Science

Locations

Charles Drew University of Medicine and Science

Los Angeles, California, United States

Countries

United States

References

Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.

Reference Type: DERIVED

PMID: 33166419 (View on PubMed)

Other Identifiers

U54RR014616

Identifier Type: NIH

Identifier Source: secondary_id

View Link

03-02-519

Identifier Type: -

Identifier Source: org_study_id