Insulin Glargine at Bedtime or in AM Versus NPH
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: 1- Insulin glargine QHS; 2 - Insulin glargine QAM; 3 - NPH insulin QHS
Intervention description: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL); Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL); NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Glargine; Type 2 diabetes; Basal insulin

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.
    

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.