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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00467649
• Other study ID #: ACA401
• Status: Completed
• Phase: Phase 4
• First received: April 27, 2007
• Last updated: March 26, 2015
• Start date: May 2007
• Est. completion date: April 2008

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• pramlintide acetate (Symlin)
subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals
• rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine])
subcutaneous injection, dosing based on titration guidelines
• basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
subcutaneous injection, dosing based on titration guidelines

Locations

Country	Name	City	State
United States	Research Site	Aiken	South Carolina
United States	Research Site	Albany	New York
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Aurora	Colorado
United States	Research Site	Austin	Texas
United States	Research Site	Baltimore	Maryland
United States	Research Site	Bartlett	Tennessee
United States	Research Site	Baton Rouge	Louisiana
United States	Research Site	Bridgeville	Pennsylvania
United States	Research Site	Butte	Montana
United States	Research Site	Dallas	Texas
United States	Research Site	Detroit	Michigan
United States	Research Site	Grand Rapids	Michigan
United States	Research Site	Hamilton	New Jersey
United States	Research Site	Hollywood	Florida
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Jackson	Mississippi
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Lexington	Kentucky
United States	Research Site	Loma Linda	California
United States	Research Site	Maitland	Florida
United States	Research Site	Mentor	Ohio
United States	Research Site	Miami	Florida
United States	Research Site	Nashville	Tennessee
United States	Research Site	North Miami Beach	Florida
United States	Research Site	Northport	Alabama
United States	Research Site	Olympia	Washington
United States	Research Site	Peoria	Illinois
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Plantation	Florida
United States	Research Site	Portland	Oregon
United States	Research Site	Roswell	Georgia
United States	Research Site	Spokane	Washington
United States	Research Site	St. Louis	Missouri
United States	Research Site	Staten Island	New York
United States	Research Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hypoglycemia Adverse Events	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.	36 weeks	Yes
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	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.	24 Weeks	No
Secondary	Percentage of Patients Achieving HbA1c <=7% at Week 24	This is a component of the primary endpoint	24 Weeks	No
Secondary	Percentage of Patients With no Weight Gain at Week 24	This is a component of the primary endpoint	24 Weeks	No
Secondary	Percentage of Patients With a Severe Hypoglycemia Adverse Event	This is a component of the primary endpoint.	24 Weeks	Yes
Secondary	Change in HbA1c From Baseline at Week 24	Baseline values are presented in the Baseline Characteristics section	From Baseline to Week 24	No
Secondary	Change in Body Weight From Baseline at Week 24	Baseline values are presented in the Baseline Characteristics section	From Baseline to Week 24	No
Secondary	Change in Waist Circumference From Baseline at Week 24	Baseline values are presented in the Baseline Characteristics section	From Baseline to Week 24	No
Secondary	Change in Fasting Plasma Glucose From Baseline at Week 24	Baseline values are presented in the Baseline Characteristics section	From Baseline to Week 24	No
Secondary	Fasting Serum Lipids Change From Baseline to Week 24		Baseline, week 24	No
Secondary	Phase 2: Change in HbA1c at Week 36	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 1 Baseline, Phase 2 Baseline at Week 24, Week 36	No
Secondary	Phase 2: Change in Body Weight at Week 36	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 1 Baseline, Phase 2 Baseline at Week 24, Week 36	No