Insulin Glargine Versus Twice-Daily NPH

NCT00687453 | Terminated Phase 4 Results DMC

• 2 other identifiers: 03-02-519U54RR014616
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Glargine; Type 2 diabetes; Basal insulin

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c Change From Baseline

  Baseline to 6 months

Secondary Outcomes (6)

• Frequency of Pre-supper Glucose Readings 130 mg/dL or Less, Change From Baseline

  6 months

• Frequency of Total Hypoglycemic Reactions

  6 months

• Frequency of Severe Hypoglycemic Reactions

  6 months

• Body Mass Index Change From Baseline

  Baseline and 6 months

• Total Daily Insulin Dose

  Baseline and 6 months

Study Arms (2)

Insulin glargine injected at bedtime

EXPERIMENTAL

Insulin glargine injected at bedtime

Drug: Insulin glargine at bedtime instead of NPH

NPH insulin injected twice-daily

ACTIVE COMPARATOR

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

Drug: NPH twice-daily

Interventions

Insulin glargine at bedtime instead of NPH DRUG

Insulin glargine at bedtime substituting for NPH insulin at bedtime

Also known as: Trade name: Lantus

Insulin glargine injected at bedtime

NPH twice-daily DRUG

Addition of morning NPH to bedtime NPH

Also known as: (Generic)

NPH insulin injected twice-daily

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charles Drew University of Medicine and Science: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Charles Drew University of Medicine and Science

Los Angeles, California, 90059, United States

Location

Related Publications (1)

• 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.

  PMID: 33166419 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Drugs, Generic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Limitations and Caveats

Early termination leading to smaller than anticipated enrollment.

Results Point of Contact

• Title: Stanley H. Hsia, MD
• Organization: Charles R. Drew University of Medicine and Science

stanleyhsia@cdrewu.edu

323-357-3633

Study Officials

• Stanley Hsia, MD

  Charles Drew University of Medicine and Science

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: May 30, 2008
• Study Start: February 1, 2003
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: November 2, 2023
• Results First Posted: October 7, 2010

Record last verified: 2023-10

Locations

US (1)