Comparison of Insulin Mix25 Versus Mix50 (CLASSIFY)
This study is currently recruiting participants.
Verified May 2013 by Eli Lilly and Company
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01773473
First received: January 18, 2013
Last updated: May 14, 2013
Last verified: May 2013
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Purpose
The purpose of this study is to determine the efficacy and safety of insulin Lispro Mix25 (LM25) compared to insulin Lispro Mix50 (LM50) as an insulin starter in participants with Type 2 diabetes mellitus (T2DM).
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Insulin Lispro Mix25 Drug: Insulin Lispro Mix50 |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison Between Low Mixed Insulin and Mid Mixed Insulin AS Starter Insulin For Patients With TYpe 2 Diabetes Mellitus (CLASSIFY Study) |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Change from Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percentage of Participants Achieving HbA1c of <7% or ≤6.5% at 26 Weeks [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
- Change from Baseline in Fasting Serum Glucose at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
- Change from Baseline in Body Weight at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
- Number of Hypoglycemic Events at 26 Weeks (Incidence) [ Time Frame: 26 Weeks ] [ Designated as safety issue: Yes ]
- Insulin Dose at 26 Weeks [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
- Change from Baseline in 1,5-Anhydroglucitol (1,5-AG) at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Insulin Lispro Mix25
Insulin Lispro Mix25 administered subcutaneously (SC) using prefilled pen twice daily for 26 weeks.
|
Drug: Insulin Lispro Mix25
Administered SC
Other Name: LY275585-75
|
|
Experimental: Insulin Lispro Mix50
Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
|
Drug: Insulin Lispro Mix50
Administered SC
Other Name: LY275585-50
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have a diagnosis of Type 2 Diabetes Mellitus for at least 6 months
- Have been taking sulfonylureas, biguanide, thiazolidinedione, alpha-glucosidase inhibitor, glinide, or dipeptidyl peptidase IV inhibitor, or any combination of these
- Have a qualifying hemoglobin A1c value ≥7.0% and ≤11.0% at screening
- Have a body mass index (BMI) ≥18.5 and <35.0 kilogram per square meter (kg/m^2)
- Have given written informed consent to participate in the study in accordance with local regulations and the ethical review board (ERB) governing the study site
Exclusion Criteria:
- Have a diagnosis of type 1 diabetes
- Have had more than 1 episode of severe hypoglycemia within the 6 months before screening
- Have any of the following cardiovascular conditions within 3 months prior to screening: acute myocardial infarction, New York Heart Association class III or class IV heart failure, or cerebrovascular accident (stroke)
- Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase levels ≥3.0 times the upper limit of the reference range at screening, as determined by the central laboratory
- Have an estimated creatinine clearance (CrCl), Cockcroft-Gault formula <30 milliliter per minute (mL/min), as determined by the central laboratory at screening
- Have evidence of a significant, active, uncontrolled endocrine or autoimmune abnormality, as judged by the investigator
- Have an active or untreated malignancy or have been in remission from a clinically significant malignancy for <5 years
- Have any other condition (such as, known drug or alcohol abuse or a psychiatric disorder) that may prevent the participants from following and completing the protocol
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01773473
Contacts
| Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 |
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. | Recruiting |
| Beijing, China, 100029 | |
| Contact: Eli Lilly | |
| 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. | Not yet recruiting |
| Changsha, China, 410013 | |
| Contact: Eli Lilly | |
| 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. | Recruiting |
| Chongqing, China, 404000 | |
| Contact: Eli Lilly | |
| 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. | Recruiting |
| Nanjing, China, 210028 | |
| Contact: Eli Lilly | |
| 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. | Recruiting |
| Shanghai, China, 200092 | |
| Contact: Eli Lilly | |
| 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. | Recruiting |
| Urumuqi, China | |
| Contact: Eli Lilly | |
| 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. | Not yet recruiting |
| Zhengzhou, China, 450052 | |
| Contact: Eli Lilly | |
| India | |
| 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. | Not yet recruiting |
| Bangalore, India, 560038 | |
| Contact: Eli Lilly | |
| 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. | Not yet recruiting |
| Hyderabaad, India, 500 034 | |
| Contact: Eli Lilly | |
| 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. | Not yet recruiting |
| Mohali, India, 160062 | |
| Contact: Eli Lilly | |
| 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. | Not yet recruiting |
| Mumbai, India, 400053 | |
| Contact: Eli Lilly | |
| Japan | |
| 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. | Not yet recruiting |
| Hiroshima, Japan, 738-8503 | |
| Contact: Eli Lilly | |
| 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. | Not yet recruiting |
| Hokkaido, Japan, 050-0073 | |
| Contact: Eli Lilly | |
| 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. | Not yet recruiting |
| Ibaraki, Japan, 302-0118 | |
| Contact: Eli Lilly | |
| 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. | Not yet recruiting |
| Kagoshima, Japan, 895-0052 | |
| Contact: Eli Lilly | |
| 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. | Not yet recruiting |
| Kumamoto, Japan, 862-0976 | |
| Contact: Eli Lilly | |
| 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. | Not yet recruiting |
| Miyagi, Japan, 985-0835 | |
| Contact: Eli Lilly | |
| 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. | Not yet recruiting |
| Nagano, Japan, 399-0006 | |
| Contact: Eli Lilly | |
| 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. | Not yet recruiting |
| Okayama, Japan, 700-0013 | |
| Contact: Eli Lilly | |
| 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. | Not yet recruiting |
| Osaka, Japan, 530-0001 | |
| Contact: Eli Lilly | |
| 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. | Not yet recruiting |
| Saitama, Japan, 350-1305 | |
| Contact: Eli Lilly | |
| 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. | Not yet recruiting |
| Tochigi, Japan, 329-0433 | |
| Contact: Eli Lilly | |
| 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. | Not yet recruiting |
| Tokyo, Japan, 206-0633 | |
| Contact: Eli Lilly | |
| 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. | Not yet recruiting |
| Yamaguchi, Japan, 750-0815 | |
| Contact: Eli Lilly | |
| Korea, Republic of | |
| 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. | Recruiting |
| Daejeon, Korea, Republic of, 302-799 | |
| Contact: Eli Lilly | |
| 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. | Recruiting |
| Incheon, Korea, Republic of, 403-720 | |
| Contact: Eli Lilly | |
| 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. | Recruiting |
| Jeju Special Self-Governing Pr, Korea, Republic of, 690-767 | |
| Contact: Eli Lilly | |
| 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. | Recruiting |
| Seoul, Korea, Republic of, 137-701 | |
| Contact: Eli Lilly | |
| 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. | Recruiting |
| Suwon-City, Korea, Republic of, 442-723 | |
| Contact: Eli Lilly | |
| Turkey | |
| 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. | Not yet recruiting |
| Ankara, Turkey, 06500 | |
| Contact: Eli Lilly | |
| 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. | Not yet recruiting |
| Antalya, Turkey, 07070 | |
| Contact: Eli Lilly | |
| 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. | Not yet recruiting |
| Gaziantep, Turkey, 27070 | |
| Contact: Eli Lilly | |
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 - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
No publications provided
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT01773473 History of Changes |
| Other Study ID Numbers: | 14675, F3Z-CR-IOQI |
| Study First Received: | January 18, 2013 |
| Last Updated: | May 14, 2013 |
| Health Authority: | Japan: Institutional Review Board South Korea: Institutional Review Board China: Ethics Committee Turkey: Ministry of Health India: Ministry of Health |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Insulin LISPRO Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013