Phase 4
Completed N=113
A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00467649 ↗Enrolled (actual)
113
Serious AEs
2.9%
Results posted
Jun 2009
Primary outcomePrimary: The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia — 30.4; 10.7 Percent — p=0.0180
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia |
30.4; 10.7 | 0.0180 sig |
| SECONDARY Percentage of Patients Achieving HbA1c <=7% at Week 24 |
44.6; 55.4 | — |
| SECONDARY Percentage of Patients With no Weight Gain at Week 24 |
46.4; 14.3 | — |
| SECONDARY Percentage of Patients With a Severe Hypoglycemia Adverse Event |
0.0; 0.0 | — |
| SECONDARY Change in HbA1c From Baseline at Week 24 |
-1.11; -1.27 | — |
| SECONDARY Change in Body Weight From Baseline at Week 24 |
0.02; 4.65 | — |
| SECONDARY Change in Waist Circumference From Baseline at Week 24 |
-0.63; 2.17 | — |
| SECONDARY Change in Fasting Plasma Glucose From Baseline at Week 24 |
-29.0; -37.8 | — |
| SECONDARY Fasting Serum Lipids Change From Baseline to Week 24 |
-1.81; 5.27; 1.11; 1.65; 2.36; 9.12 | — |
| SECONDARY Phase 2: Change in HbA1c at Week 36 |
8.35; 8.03; 7.85; 8.38; -1.96; -0.68 | — |
| SECONDARY Phase 2: Change in Body Weight at Week 36 |
109.98; 104.83; 104.42; 105.30; -0.80; 1.34 | — |
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
Data sourced from ClinicalTrials.gov (NCT00467649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.