Insulin Glargine at Bedtime or in AM Versus NPH

NCT00686712 | Completed Phase 4 Results DMC

• 2 other identifiers: 03-02-524U54RR014616
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

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 Glucose Readings < 130 mg/dL

  6 months

• Frequency of Total Hypoglycemic Reactions

  6 months

• Frequency of Severe Hypoglycemic Reactions

  6 months

• Body Mass Index Change From Baseline

  6 months

• Total Daily Insulin Dose

  6 months

Study Arms (3)

1 - Insulin glargine QHS

EXPERIMENTAL

Insulin glargine injected subcutaneously once daily at bedtime

Drug: 1- Insulin glargine QHS

2 - Insulin glargine QAM

EXPERIMENTAL

Insulin glargine injected subcutaneously once daily in the morning

Drug: 2 - Insulin glargine QAM

3 - NPH Insulin QHS

ACTIVE COMPARATOR

NPH insulin injected subcutaneously once daily at bedtime

Drug: 3 - NPH insulin QHS

Interventions

1- Insulin glargine QHS DRUG

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

Also known as: Trade name: Lantus

1 - Insulin glargine QHS

2 - Insulin glargine QAM DRUG

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

Also known as: Trade name: Lantus

2 - Insulin glargine QAM

3 - NPH insulin QHS DRUG

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

Also known as: (Generic)

3 - NPH Insulin QHS

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
• 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

You may not qualify if:

• 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.

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 (2)

• 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

• 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.

  PMID: 21146881 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: May 22, 2017
• Results First Posted: October 7, 2010

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)