A Study for Patients With Diabetes Mellitus (IOPA) - Full Text View

Purpose

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 1 Diabetes Type 2

Drug Information available for: Insulin human Insulin lispro

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint [ Time Frame: Baseline and 12 weeks of each treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment [ Time Frame: Baseline and at 12 weeks of each treatment ] [ Designated as safety issue: Yes ]
Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks of each treatment ] [ Designated as safety issue: Yes ]
Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment [ Time Frame: Baseline and 12 weeks of each treatment ] [ Designated as safety issue: No ]
Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5% [ Time Frame: 12 weeks of each treatment ] [ Designated as safety issue: Yes ]
Number of Participants With Laboratory Parameters Significantly Different From Baseline [ Time Frame: Baseline and 12 weeks of each treatment ] [ Designated as safety issue: Yes ]
Hypoglycemia Rate Per Participant Per 30 Days [ Time Frame: over 12 weeks of each treatment period ] [ Designated as safety issue: Yes ]

Enrollment:	117
Study Start Date:	January 2007
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00420095 History of Changes
Other Study ID Numbers:	11423, F3Z-GH-IOPA
Study First Received:	January 5, 2007
Results First Received:	January 7, 2009
Last Updated:	June 9, 2009
Health Authority:	China: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

diabetes
type 1
type 2

Additional relevant MeSH terms:

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

Immune System Diseases
Insulin LISPRO
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013