A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00467649
First received: April 27, 2007
Last updated: June 4, 2014
Last verified: June 2014

April 27, 2007
June 4, 2014
May 2007
April 2008   (final data collection date for primary outcome measure)
The Percentage 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 ]
A severe hypoglycemia is defined as an event during which the patient required the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention.
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
  • Percentage of Patients Achieving HbA1c <=7% at Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    This is a component of the primary endpoint
  • Percentage of Patients With no Weight Gain at Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    This is a component of the primary endpoint
  • Percentage of Patients With a Severe Hypoglycemia Adverse Event [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
    This is a component of the primary endpoint.
  • Change in HbA1c From Baseline at Week 24 [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
    Baseline values are presented in the Baseline Characteristics section
  • Change in Body Weight From Baseline at Week 24 [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
    Baseline values are presented in the Baseline Characteristics section
  • Change in Waist Circumference From Baseline at Week 24 [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
    Baseline values are presented in the Baseline Characteristics section
  • Change in Fasting Plasma Glucose From Baseline at Week 24 [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
    Baseline values are presented in the Baseline Characteristics section
  • Fasting Serum Lipids Change From Baseline to Week 24 [ Time Frame: Baseline, week 24 ] [ Designated as safety issue: No ]
  • Phase 2: Change in HbA1c at Week 36 [ Time Frame: Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36 ] [ Designated as safety issue: No ]
    Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only).
  • Phase 2: Change in Body Weight at Week 36 [ Time Frame: Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36 ] [ Designated as safety issue: No ]
    Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only).
  • 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 ]
Hypoglycemia Adverse Events [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]

MILD: patient reported symptoms consistent with hypoglycemia that may or may not have been documented by glucose monitoring at the time of symptoms. Symptoms did not greatly interrupt or interfere with the patients daily activities. Symptoms dissipated spontaneously or upon eating.

MODERATE: Patient reported symptoms consistent with hypoglycemia that may or may not have been documented by glucose monitoring at the time of symptoms. Symptoms interrupted or interfered with the patients daily activities and required immediate self treatment (e.g. carbohydrate ingestion).

SEVERE: Patient required the assistance of another individual (including aid in ingestion of oral carbohydrate): and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention.

Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: pramlintide acetate (Symlin)
    subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals
    Other Name: Symlin
  • Drug: rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine])
    subcutaneous injection, dosing based on titration guidelines
  • Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
    subcutaneous injection, dosing based on titration guidelines
  • Experimental: Group A
    Interventions:
    • Drug: pramlintide acetate (Symlin)
    • Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
  • Active Comparator: Group B
    Interventions:
    • Drug: rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine])
    • Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
Peyrot M, Rubin RR, Polonsky WH, Best JH. Patient reported outcomes in adults with type 2 diabetes on basal insulin randomized to addition of mealtime pramlintide or rapid-acting insulin analogs. Curr Med Res Opin. 2010 May;26(5):1047-54. doi: 10.1185/03007991003634759.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00467649
ACA401
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
AstraZeneca
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP