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 effectiveness and safety of lispro protamine suspension as compared to insulin detemir as basal plus mealtime insulin therapy in patients with type 1 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2008

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 (NPL), 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, BID, within 15 minutes before meals, SC injection x 32 weeks.
• Drug: Insulin Levemir
  • Patient specific dose insulin Levemir BID SC injection x 32 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Insulin Lispro Protamine Suspension twice daily
• Active Comparator: 2
  • Insulin Levemir (detemir) SC twice daily.

Primary Measures

• Change in HbA1c from baseline.
  • Time Frame: 32 weeks
    Safety Issue?: Yes

Secondary Measures

• Actual and change from baseline HbA1c value.
  • Time Frame: 8,16, 24, 32 Weeks
    Safety Issue?: Yes
• Percentage of patients with 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) profiles and glycemic variability from these profiles.
  • Time Frame: 32 Weeks
    Safety Issue?: No
• The incidence, 30-day adjusted rate, and 1-year adjusted rate of self-reported hypoglycemic episodes (throughout the study and at endpoint), including nocturnal and non-nocturnal; and severe hypoglycemia.
  • Time Frame: 32 Weeks
    Safety Issue?: Yes
• Absolute body weight (kg) and incremental weight change.
  • Time Frame: 32 Weeks
    Safety Issue?: No
• Treatment-emergent adverse events (TEAEs).
  • Time Frame: Every visit
    Safety Issue?: Yes
• 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 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 Sponsor: Eli Lilly and Company

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 July 02, 2009

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