Insulin Glargine at Bedtime or in AM Versus NPH

NCT ID: NCT00686712

Last Updated: 2017-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 108 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 a single morning injection of glargine or once-nightly NPH insulin in ethnic minority type 2 diabetic patients inadequately controlled on combination oral agents.

Detailed 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.

Conditions

Type 2 Diabetes Mellitus

Study Design

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

Study Groups

1 - Insulin glargine QHS

Insulin glargine injected subcutaneously once daily at bedtime

Group Type: EXPERIMENTAL

1- Insulin glargine QHS

Intervention Type: DRUG

Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings \<120 mg/dL)

2 - Insulin glargine QAM

Insulin glargine injected subcutaneously once daily in the morning

Group Type: EXPERIMENTAL

2 - Insulin glargine QAM

Intervention Type: DRUG

Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings \<120 mg/dL)

3 - NPH Insulin QHS

NPH insulin injected subcutaneously once daily at bedtime

Group Type: ACTIVE_COMPARATOR

3 - NPH insulin QHS

Intervention Type: DRUG

NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses \<120 mg/dL)

Interventions

1- Insulin glargine QHS

Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings \<120 mg/dL)

Intervention Type: DRUG

2 - Insulin glargine QAM

Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings \<120 mg/dL)

Intervention Type: DRUG

3 - NPH insulin QHS

NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses \<120 mg/dL)

Intervention Type: DRUG

Other Intervention Names

Trade name: Lantus; Trade name: Lantus; (Generic)

Eligibility Criteria

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.

• 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)

Hsia SH. Insulin glargine compared to NPH among insulin-naive, 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.

Reference Type: DERIVED

PMID: 21146881 (View on PubMed)

Other Identifiers

U54RR014616

Identifier Type: NIH

Identifier Source: secondary_id

View Link

03-02-524

Identifier Type: -

Identifier Source: org_study_id