A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: pramlintide acetate (Symlin); rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine]); basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
Intervention description: subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals; subcutaneous injection, dosing based on titration guidelines; subcutaneous injection, dosing based on titration guidelines
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart; Insulin Lispro; Insulin Detemir; Insulin glulisine; Pramlintide; Insulin, Short-Acting
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Symlin; Amylin; insulin; Humalog; Novolog; Apidra

Summary:

      This will be a randomized, open label, parallel group, multicenter study. There will be two
      phases in the study. Phase 1 (Baseline to Week 24) will compare the efficacy and safety of
      regimens of basal insulin intensified with either Symlin or rapid acting insulin in patients
      with type 2 diabetes who have either been on a prior regimen of insulin for less than 6
      months and were taking less than 50 U total of insulin per day OR are candidates for the
      initiation of insulin therapy. The purpose of Phase 2 (Week 24 to Week 36) is to explore
      further intensification of diabetes regimens in patients failing to achieve HbA1c <=6.5% at
      Week 24.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a clinical diagnosis of type 2 diabetes mellitus

          -  Has an HbA1c >7.0% and ≤10.0%

          -  Has a BMI of ≥25 kg/m^2 and ≤50 kg/m^2

          -  Has been on a regimen of insulin for less than 6 months and is taking less than 50 U
             total of insulin per day, OR has not been on a pre existing insulin regimen and is a
             candidate for the initiation of basal insulin therapy

        Exclusion Criteria:

          -  Has experienced recurrent severe hypoglycemia requiring assistance during the past 6
             months

          -  Requires the use of drugs that stimulate gastrointestinal motility

          -  Has been previously treated with Symlin (or has participated in a Symlin clinical
             study)

          -  Is currently being treated with any of the following medications: *Over-the-counter
             antiobesity agents (including, but not limited to, herbal supplements) or prescription
             antiobesity agents (including orlistat [Xenical®] and sibutramine [Meridia®]); *Oral,
             intravenous, or intramuscular systemic steroids by oral or potent inhaled or
             intrapulmonary steroids that are known to have a high rate of systemic absorption;
             *Drugs that directly affect gastrointestinal motility, including but not limited to:
             dopamine antagonists (e.g., metoclopramide [Reglan®]), opiates or anticholinergics;
             and chronic (more than 10 days within a 6-month period) macrolide antibiotics such as
             erythromycin and newer derivatives; *Investigational medications

          -  Has a history or presence of any of the following: *Eating disorders (including
             anorexia and/or bulimia); *Bariatric surgery (gastric bypass, gastric banding, or
             gastroplasty)

          -  Is currently enrolled in a weight-loss program or plans to enroll in a weight-loss
             program before termination of the study

          -  Has donated blood within 30 days of study start or plans to donate blood during the
             duration of the study