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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: pramlintide acetate (Symlin)
Drug: rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine])
Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Other Outcome Measures:
  • 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.



Enrollment: 112
Study Start Date: May 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Drug: pramlintide acetate (Symlin)
subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals
Other Name: Symlin
Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
subcutaneous injection, dosing based on titration guidelines
Active Comparator: Group B 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467649

  Show 37 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00467649     History of Changes
Other Study ID Numbers: ACA401
Study First Received: April 27, 2007
Results First Received: April 10, 2009
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by AstraZeneca:
Symlin
Amylin
insulin
Humalog
Novolog
Apidra

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Glargine
Pramlintide
Insulin glulisine
Insulin
Insulin Aspart
Insulin Lispro
Insulin, Short-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014