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Completed

NCT Number: NCT00467649

A 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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Northport, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pramlintide acetate (Symlin)

Drug

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

Other names: Symlin

rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine])

Drug

subcutaneous injection, dosing based on titration guidelines

basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])

Drug

subcutaneous injection, dosing based on titration guidelines

Primary outcomes

  1. 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

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

    Time frame: 24 Weeks

    This is a component of the primary endpoint

  2. Percentage of Patients With no Weight Gain at Week 24

    Time frame: 24 Weeks

    This is a component of the primary endpoint

  3. Percentage of Patients With a Severe Hypoglycemia Adverse Event

    Time frame: 24 Weeks

    This is a component of the primary endpoint.

  4. Change in HbA1c From Baseline at Week 24

    Time frame: From Baseline to Week 24

    Baseline values are presented in the Baseline Characteristics section

  5. 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

  6. 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

  7. 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

  8. Fasting Serum Lipids Change From Baseline to Week 24

    Time frame: Baseline, week 24

  9. 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).

  10. 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).

Other outcomes

  1. Hypoglycemia Adverse Events

    Time frame: 36 weeks

    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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 1, 2007
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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