A Study for Patients With Diabetes Mellitus (IOPA)

NCT00420095 | Completed Phase 4 Results

• 2 other identifiers: 11423F3Z-GH-IOPA
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to compare glycemic control (HbA1c) in Chinese patients with type 1 or type 2 diabetes when treated with insulin lispro low mixture and human insulin 30/70.

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Keywords

diabetes; type 1; type 2

Outcome Measures

Primary Outcomes (1)

• Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint

  Glycosylated hemoglobin reflects the average blood glucose level over the previous 12 weeks of treatment.

  Baseline and 12 weeks of each treatment

Secondary Outcomes (6)

• Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment

  Baseline and at 12 weeks of each treatment

• Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment

  Baseline and 12 weeks of each treatment

• Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment

  Baseline and 12 weeks of each treatment

• Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5%

  12 weeks of each treatment

• Number of Participants With Laboratory Parameters Significantly Different From Baseline

  Baseline and 12 weeks of each treatment

Study Arms (2)

1

ACTIVE COMPARATOR

Human insulin mix 30/70

Drug: Human insulin 30/70

2

EXPERIMENTAL

Insulin lispro low mix

Drug: Insulin lispro low mix

Interventions

Human insulin 30/70 DRUG

Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks

1

Insulin lispro low mix DRUG

Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks

Also known as: LM, Low Mix, Humalog

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically diagnosed type 1or type 2 diabetes for at least 2 months
• Aged between 18 and 70 (inclusive)
• Have been treated with human insulin mix 30/70 twice daily for at least 2 months prior to entering the study
• Have glycosylated hemoglobin (Hb1Ac) between 1.2 and 1.7 times the upper limit of normal reference range within 2 weeks prior to or at Visit 1
• Compliance with diet and insulin therapy and performs regular blood glucose monitoring

You may not qualify if:

• Have used oral antidiabetic agents within 30 days prior to entry into the study
• Receive a total daily dose of insulin \>2 units/kilogram
• Have had more than two episodes of severe hypoglycemia within 6 months prior to entry into the study
• Have a body mass index \>35 kilograms per square meter (kg/m2)
• Receive chronic systemic glucocorticoid therapy

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (4)

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.

Guangzhou, 510120, China

Location

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.

Hangzhou, 310003, China

Location

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.

Harbin, 150086, China

Location

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.

Hefei, 230022, China

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; 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

1-800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5PM 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 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 5, 2007
• First Posted: January 9, 2007
• Study Start: January 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: June 17, 2009
• Results First Posted: June 5, 2009

Record last verified: 2009-06

Locations

CN (4)