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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00467649 |
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Date of registration:
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27/04/2007 |
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Primary sponsor: |
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Public title:
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A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes
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Scientific title:
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A Phase 4, Randomized, Open Label, Parallel Group, Multicenter Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes |
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Date of first enrolment:
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April 2007 |
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Target sample size:
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113 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00467649 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Lisa Porter, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Amylin Pharmaceuticals, LLC. |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes Mellitus
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Intervention(s)
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Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
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Drug: pramlintide acetate
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Drug: rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine])
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Primary Outcome(s)
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The Proportion of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia
[Time Frame: 24 Weeks]
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Secondary Outcome(s)
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Change in Body Weight From Baseline at Week 24
[Time Frame: 24 Weeks]
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Change in Fasting Plasma Glucose From Baseline
[Time Frame: 24 Weeks]
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Change in HbA1c From Baseline at Week 24
[Time Frame: 24 Weeks]
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Change in Waist Circumference From Baseline
[Time Frame: 24 Weeks]
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Fasting Serum Lipids Change From Baseline at Week 24
[Time Frame: 24 Weeks]
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Phase 2: Change in Body Weight at Week 36
[Time Frame: 36 Weeks]
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Phase 2: Change in HbA1c at Week 36
[Time Frame: 36 Weeks]
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Proportion of Patients Achieving HbA1c <=7% at Week 24
[Time Frame: 24 Weeks]
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Proportion of Patients With a Severe Hypoglycemia Adverse Event
[Time Frame: 24 Weeks]
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Proportion of Patients With no Weight Gain at Week 24
[Time Frame: 24 Weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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