A Study for Type 2 Diabetic Patients

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00548808
First received: October 22, 2007
Last updated: August 20, 2010
Last verified: August 2010
  Purpose

The purpose of the study is to compare the insulin lispro low mixture (1, 2 or 3 daily injections) with insulin glargine (alone or with 1, 2 or 3 insulin lispro daily injections) on lowering the blood sugar level


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Insulin lispro low mixture
Drug: Insulin glargine
Drug: Insulin lispro
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Insulin Lispro Low Mixture With Insulin Glargine When Initiating and Intensifying Insulin Therapy As Required in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Oral Antihyperglycemic Medication

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Hemoglobin A1c (HbA1c) Over Time [ Time Frame: Baseline, 16 Weeks, 32 Weeks, 48 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time [ Time Frame: 16 weeks, 32 weeks, 48 weeks ] [ Designated as safety issue: No ]
  • 7-point Self-monitored Blood Glucose Profiles [ Time Frame: Baseline, 16 weeks, 32 weeks, 48 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Postprandial Blood Glucose Over Time [ Time Frame: Baseline, 16 weeks, 32 weeks, 48 weeks ] [ Designated as safety issue: No ]
    The change in blood glucose was evaluated by the GlycoMark™ test. GlycoMark measures levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma, allowing for the short- to intermediate-term monitoring of glycemic control in patients with diabetes. When 1,5 AG values decrease, serum glucose levels increase.

  • Daily Total Insulin Dose (U/Day) at 16, 32, and 48 Weeks [ Time Frame: 16 weeks, 32 weeks, 48 weeks ] [ Designated as safety issue: No ]
  • Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks [ Time Frame: 16 weeks, 32 weeks, 48 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles [ Time Frame: baseline, 48 weeks ] [ Designated as safety issue: Yes ]
  • Safety: Number of Participants With Serious and Non-Serious Adverse Events [ Time Frame: baseline through 48 weeks ] [ Designated as safety issue: Yes ]
    Safety was assessed via serious adverse events (SAEs) and AEs, the details of which are listed in the Reported Adverse Event section.


Enrollment: 426
Study Start Date: November 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin lispro low mixture
Insulin lispro low mixture (1, 2 or 3 daily injections)
Drug: Insulin lispro low mixture
Dose depending on patient's need; subcutaneous injection before meal; start with once-daily injection before evening meal for 48 weeks, may add second injection before breakfast at any time during the treatment period if required, and may further add third injection before lunch at any time in the remainder of the treatment period if required.
Other Name: LY275585[P]
Active Comparator: Insulin glargine
Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
Drug: Insulin glargine
Dose depending on patient's need; one daily subcutaneous injection before bedtime for 48 weeks
Drug: Insulin lispro
Dose depending on patient's need; subcutaneous injection before meal; may start once-daily injection before meal (e.g. lunch if the highest blood glucose value is measured before dinner) on top of insulin glargine at any time of the treatment period if required, and may further add second or even third injection in the remainder of the treatment period if required.
Other Name: LY275585

  Eligibility

Ages Eligible for Study:   30 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Receiving oral antihyperglycemic medications (including metformin) without insulin injection in the last 90 days
  • Hemoglobin A1c (HbA1c) equal to or greater than 7.0% but less than 11.0%
  • Willing to receive insulin injection while continuing to take the prestudy oral antihyperglycemic medications
  • Able to perform self monitoring of blood glucose

Exclusion Criteria:

  • Are taking any other glucose-lowering agents other than metformin, sulfonylurea or Thiazolidinedione (Pioglitazone)
  • Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks, or for a total of 30 days or more, in the last 24 weeks
  • Have a body mass index greater than 35 kg/m2
  • History or presence of kidney disease
  • Have cardiac disease (Class III or IV)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548808

  Show 25 Study Locations
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

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00548808     History of Changes
Other Study ID Numbers: 11541, F3Z-CR-IOPH
Study First Received: October 22, 2007
Results First Received: August 20, 2010
Last Updated: August 20, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Brazil: National Health Surveillance Agency
Canada: Health Canada
China: Food and Drug Administration
India: Indian Council of Medical Research
Mexico: Federal Commission for Sanitary Risks Protection
South Korea: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Glargine
Insulin
Insulin Lispro
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014