Comparison of Two Basal Insulin Therapies for Patients With Type 1 Diabetes

Official Title: “Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Insulin Detemir) in Basal-Bolus Therapy for Patients With Type 1 Diabetes”

The purpose of this study is to examine the efficacy and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin combined with mealtime insulin therapy in patients with type 1 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

Phase 3b, randomized, multicenter, multinational, open-label, two-arm, active control, parallel study to determine safety, efficacy, and noninferiority of basal analog insulin lispro protamine suspension (ILPS, also referred to as NPL [neutral protamine Hagedorn]), injected two times a day, compared with basal analog insulin detemir, injected two times a day, as measured by change in hemoglobin A1c (HbA1c) from baseline (Visit 2) to 32 weeks in adult patients with type 1 diabetes when used in combination with bolus insulin lispro, injected three times a day.

Intervention(s) in this Clinical Trial

• Drug: Insulin Lispro Protamine Suspension
  • Patient specific dose, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks.
• Drug: Insulin Levemir
  • Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Insulin Lispro Protamine Suspension
  • Insulin Lispro Protamine Suspension twice daily
• Active Comparator: Detemir
  • Insulin Levemir (detemir) subcutaneous (SC) twice daily.

Primary Measures

• Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
  • Time Frame: baseline and 32 weeks
    Safety Issue?: No

Secondary Measures

• Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values
  • Time Frame: Baseline, 8,16, 24, 32 Weeks
    Safety Issue?: No
• Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5%
  • Time Frame: 32 Weeks
    Safety Issue?: No
• 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint
  • Time Frame: 32 Weeks
    Safety Issue?: No
• Glycemic Variability at Endpoint
  • Time Frame: 32 Weeks
    Safety Issue?: No
• Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint
  • Time Frame: Baseline to 32 Weeks
    Safety Issue?: Yes
• 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint
  • Time Frame: baseline to 32 weeks
    Safety Issue?: Yes
• 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint
  • Time Frame: baseline to 32 weeks
    Safety Issue?: No
• Change From Baseline in Absolute Body Weight at 32 Week Endpoint
  • Time Frame: Baseline, 32 Weeks
    Safety Issue?: No
• Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus])
  • Time Frame: 32 Weeks
    Safety Issue?: No
• Insulin Dose (Total and By Component [Basal and Bolus])
  • Time Frame: 32 weeks
    Safety Issue?: No

Inclusion Criteria:

• Clinical diagnosis of type 1 diabetes for one year or more
• Age 18 years or older
• Body mass index (BMI) less than or equal to 35 kilograms per square meter (kg/m2)
• Have a hemoglobin A1c (HbA1c) 1.2 to 2.0 times the upper limit of the normal (ULN) reference range within 30 days prior to Visit 1 or collected and analyzed at a local laboratory at Visit 1
• As determined by the investigator, are capable and willing to do the following:
• perform self monitoring of blood glucose (SMBG),
• complete patient diaries as required for this protocol,
• use the insulin injection device(s) according to the instructions provided,
• are receptive to diabetes education,
• comply with the required study visits.

Exclusion Criteria:

• Have taken any oral antihyperglycemic medications (OAMs) within 3 months prior to Visit 1.
• Have had more than one episode of severe hypoglycemia, as defined in the Abbreviations and Definitions section of the protocol, within 6 months prior to entry into the study
• Are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable or women who are breastfeeding
• Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, intraocular, and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding Visit 1.
• Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Eli Lilly and Company Industry

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00487240

Study ID Number: 10937

ClinicalTrials.gov Identifier: NCT00487240

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry