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

NCT00487240 | Completed Phase 3 Results

• 2 other identifiers: 10937F3Z-MC-IOOZ
• Study Type: interventional
• Target: 387
• Locations: 9 countries
• Sites: 28

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

diabetes; type 1

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint

  baseline and 32 weeks

Secondary Outcomes (10)

• Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values

  Baseline, 8,16, 24, 32 Weeks

• Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5%

  32 Weeks

• 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint

  32 Weeks

• Glycemic Variability at Endpoint

  32 Weeks

• Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint

  Baseline to 32 Weeks

Study Arms (2)

Insulin Lispro Protamine Suspension

EXPERIMENTAL

Insulin Lispro Protamine Suspension twice daily

Drug: Insulin Lispro Protamine Suspension

Detemir

ACTIVE COMPARATOR

Insulin Levemir (detemir) subcutaneous (SC) twice daily.

Drug: Insulin Levemir

Interventions

Insulin Lispro Protamine Suspension DRUG

Patient specific dose, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks.

Also known as: ILPS, NPL, Humalog, LY275585

Insulin Lispro Protamine Suspension

Insulin Levemir DRUG

Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks

Detemir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (28)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Idaho Falls, Idaho, 83404, United States

Location

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Springfield, Illinois, 62704, United States

Location

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Topeka, Kansas, 66606, United States

Location

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San Antonio, Texas, 78229, United States

Location

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Buenos Aires, C1213AAH, Argentina

Location

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La Plata, B1902AWL, Argentina

Location

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Wollongong, New South Wales, Australia

Location

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Box Hill, Victoria, 3128, Australia

Location

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Fortaleza, 60120-020, Brazil

Location

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São Paulo, 04020041, Brazil

Location

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Athens, 11527, Greece

Location

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Thessaloniki, 56429, Greece

Location

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Budapest, 1088, Hungary

Location

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Mosonmagyaróvár, 9200, Hungary

Location

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Pécs, 7623, Hungary

Location

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Szentes, 6600, Hungary

Location

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Zalaegerszeg, 8900, Hungary

Location

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Guadalajara, 44600, Mexico

Location

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Pachuca, 42090, Mexico

Location

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Puebla City, 72160, Mexico

Location

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Baia Mare, 430071, Romania

Location

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Brasov, 500326, Romania

Location

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Bucharest, 70266, Romania

Location

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Iași, 6600, Romania

Location

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Arkhangelsk, 163045, Russia

Location

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Moscow, 115478, Russia

Location

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Rostov-on-Don, 344022, Russia

Location

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Saint Petersburg, 193257, Russia

Location

Related Publications (1)

• Chacra AR, Kipnes M, Ilag LL, Sarwat S, Giaconia J, Chan J; COMPLETE T1D investigators. Comparison of insulin lispro protamine suspension and insulin detemir in basal-bolus therapy in patients with Type 1 diabetes. Diabet Med. 2010 May;27(5):563-9. doi: 10.1111/j.1464-5491.2010.02986.x.

  PMID: 20536953 RESULT

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 14, 2007
• First Posted: June 18, 2007
• Study Start: June 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: November 4, 2010
• Results First Posted: September 25, 2009

Record last verified: 2010-10

Locations

AU (2); RO (4); AR (2); US (4); HU (5); ME (3); RU (4); BR (2); GR (2)