Clinical trial NCT00687453: Insulin Glargine Versus Twice-Daily NPH
Official title: The Utility of Insulin Glargine (Lantus) Compared to NPH in Ethnic Minority Type 2 Diabetic Subjects on Combination Insulin-Oral Agent Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Glargine
Type 2 diabetes
Basal insulin
Lead sponsor: Charles Drew University of Medicine and Science
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2008-05-30
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Hemoglobin A1c Change From Baseline
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Frequency of Pre-supper Glucose Readings 130 mg/dL or Less, Change From Baseline
timeFrame: 6 months
measure: Frequency of Total Hypoglycemic Reactions
timeFrame: 6 months
measure: Frequency of Severe Hypoglycemic Reactions
timeFrame: 6 months
measure: Body Mass Index Change From Baseline
timeFrame: Baseline and 6 months
measure: Total Daily Insulin Dose
timeFrame: Baseline and 6 months
measure: Any Adverse Event Other Than Hypoglycemia
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Charles Drew University of Medicine and Science
state: California
Study officials:
affiliation: Charles Drew University of Medicine and Science
name: Stanley Hsia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.