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Completed

NCT Number: NCT00420095

A Study for Patients With Diabetes Mellitus (IOPA)

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary 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., Guangzhou, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Human insulin 30/70

Drug

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

Insulin lispro low mix

Drug

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

Other names: LM, Low Mix, Humalog

Primary outcomes

  1. Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint

    Time frame: Baseline and 12 weeks of each treatment

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

Secondary outcomes

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

    Time frame: Baseline and at 12 weeks of each treatment

    Changes in glycosylated hemoglobin reflect the change in average blood glucose level between baseline and 12 weeks of treatment. Change = Baseline - Endpoint.

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

    Time frame: Baseline and 12 weeks of each treatment

    Values obtained after at least an 8 hour fast. Change = Baseline - Endpoint

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

    Time frame: Baseline and 12 weeks of each treatment

    Insulin lispro low mix was to be administered within 15 minutes of morning and evening meals. Human insulin mix 30/70 was to be administered within 30 minutes of morning and evening meals. Change = Baseline - Endpoint

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

    Time frame: 12 weeks of each treatment

    Number of patients in each treatment group achieving the target HbA1c value during 12 weeks of each treatment.

  5. Number of Participants With Laboratory Parameters Significantly Different From Baseline

    Time frame: Baseline and 12 weeks of each treatment

    Number of participants with laboratory parameters (hematology, chemistry, and urinalysis) that were significantly different from baseline after 12 weeks of each treatment.

  6. Hypoglycemia Rate Per Participant Per 30 Days

    Time frame: over 12 weeks of each treatment period

    Hypoglycemia rate per patient per 30 days = (number of reported hypogylcemia events/number of days within the period) * 30 days. Since this was a 2x2 cross-over design (2 treatments and 2 periods), then the hypogyclemia rate was calculated per patient for each of the 2 periods by treatment.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Comparison of HbA1c in Type 1 or Type 2 Diabetic Patients Using Insulin Treated Twice Daily With Either Insulin Lispro Low Mixture or Human Insulin Mix 30/70

Acronym: IOPA

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 9, 2007
Registry last updated
Jun 17, 2009

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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