Current partner codePEPTIDESDE
NCT00467649·Phase 4·INTERVENTIONAL

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

Status

Completed

Phase

Phase 4

Enrollment

112

Locations

37

Results

Posted

Publications

1

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

pramlintide acetate (Symlin)

subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals

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

Timeline

From registration to results.

  1. First posted

    May 1, 2007

  2. Study start

    May 2007

  3. Primary completion

    Apr 2008

  4. Study completion

    Apr 2008

  5. Results posted

    Jun 4, 2009

  6. Registry updated

    Apr 14, 2015

Outcomes

What the study measures.

Primary outcomes

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

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 outcomes

Percentage of Patients Achieving HbA1c <=7% at Week 24

Time frame · 24 Weeks

This is a component of the primary endpoint

Percentage of Patients With no Weight Gain at Week 24

Time frame · 24 Weeks

This is a component of the primary endpoint

Percentage of Patients With a Severe Hypoglycemia Adverse Event

Time frame · 24 Weeks

This is a component of the primary endpoint.

Change in HbA1c From Baseline at Week 24

Time frame · From Baseline to Week 24

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

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

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

Baseline values are presented in the Baseline Characteristics section

Fasting Serum Lipids Change From Baseline to Week 24

Time frame · Baseline, week 24

Phase 2: Change in HbA1c at Week 36

Time frame · Phase 1 Baseline, Phase 2 Baseline at Week 24, 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 2: Change in Body Weight at Week 36

Time frame · Phase 1 Baseline, Phase 2 Baseline at Week 24, 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).

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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 locations

37 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Research Site

Northport, Alabama, United States

Research Site

Phoenix, Arizona, United States

Research Site

Loma Linda, California, United States

Research Site

Aurora, Colorado, United States

Research Site

Hollywood, Florida, United States

Research Site

Maitland, Florida, United States

Research Site

Miami, Florida, United States

Research Site

North Miami Beach, Florida, United States

Research Site

Plantation, Florida, United States

Research Site

Roswell, Georgia, United States

Research Site

Peoria, Illinois, United States

Research Site

Indianapolis, Indiana, United States

Research Site

Wichita, Kansas, United States

Research Site

Lexington, Kentucky, United States

Research Site

Baton Rouge, Louisiana, United States

Research Site

Baltimore, Maryland, United States

Research Site

Detroit, Michigan, United States

Research Site

Grand Rapids, Michigan, United States

Research Site

Jackson, Mississippi, United States

Research Site

St Louis, Missouri, United States

Research Site

Butte, Montana, United States

Research Site

Las Vegas, Nevada, United States

Research Site

Hamilton, New Jersey, United States

Research Site

Albuquerque, New Mexico, United States

Related trials

More studies on Pramlintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.