| April 27, 2007 |
| April 10, 2009 |
| April 2007 |
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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 ] [ Designated as safety issue: No ] |
| To compare the efficacy and safety of regimens of basal insulin intensified with either Symlin or rapid acting insulin in patients with type 2 diabetes. [ Time Frame: 24 weeks ] |
| Complete list of historical versions of study NCT00467649 on ClinicalTrials.gov Archive Site |
- Proportion of Patients Achieving HbA1c <=7% at Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
- Proportion of Patients With no Weight Gain at Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
- Proportion of Patients With a Severe Hypoglycemia Adverse Event [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
- Change in HbA1c From Baseline at Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
- Change in Body Weight From Baseline at Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
- Change in Waist Circumference From Baseline [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
- Change in Fasting Plasma Glucose From Baseline [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
- Fasting Serum Lipids Change From Baseline at Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
- Phase 2: Change in HbA1c at Week 36 [ Time Frame: 36 Weeks ] [ Designated as safety issue: No ]
- Phase 2: Change in Body Weight at Week 36 [ Time Frame: 36 Weeks ] [ Designated as safety issue: No ]
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- To explore the effects of intensifying basal insulin regimens with either Symlin or rapid acting insulin in patients with type 2 diabetes. [ Time Frame: 24 weeks ]
- To explore the effects of further intensification of diabetes regimens in patients failing to achieve HbA1c ≤6.5% at Week 24. [ Time Frame: 36 weeks ]
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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 |
| 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 |
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. |
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| Phase IV |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Type 2 Diabetes Mellitus |
- Drug: pramlintide acetate
- Drug: rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine])
- Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
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| Completed |
| 113 |
| May 2008 |
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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
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| Both |
| 18 Years to 75 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
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| NCT00467649 |
| Lisa Porter, MD, Study Director, Amylin Pharmaceuticals |
| ACA401 |
| Amylin Pharmaceuticals, Inc. |
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| Study Director: |
Lisa Porter, MD |
Amylin Pharmaceuticals, Inc. |
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| Amylin Pharmaceuticals, Inc. |
| April 2009 |