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A Study for Patients With Diabetes Mellitus (IOPA) (IOPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00420095
Recruitment Status : Completed
First Posted : January 9, 2007
Results First Posted : June 5, 2009
Last Update Posted : June 17, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: Human insulin 30/70 Drug: Insulin lispro low mix Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2007
Primary Completion Date : January 2008
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Human insulin mix 30/70
Drug: Human insulin 30/70
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks
Experimental: 2
Insulin lispro low mix
Drug: Insulin lispro low mix
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks
Other Names:
  • LM
  • Low Mix
  • Humalog



Primary Outcome Measures :
  1. Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint [ Time Frame: Baseline and 12 weeks of each treatment ]

Secondary Outcome Measures :
  1. Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment [ Time Frame: Baseline and at 12 weeks of each treatment ]
  2. Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks of each treatment ]
  3. Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks of each treatment ]
  4. Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5% [ Time Frame: 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 ]
  6. Hypoglycemia Rate Per Participant Per 30 Days [ Time Frame: over 12 weeks of each treatment period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00420095


Locations
China
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.
Guang Zhou, China, 510120
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, China, 310003
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, China, 150086
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, China, 230022
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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

Additional Information:
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00420095     History of Changes
Other Study ID Numbers: 11423
F3Z-GH-IOPA
First Posted: January 9, 2007    Key Record Dates
Results First Posted: June 5, 2009
Last Update Posted: June 17, 2009
Last Verified: June 2009

Keywords provided by Eli Lilly and Company:
diabetes
type 1
type 2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs