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A Study for Type 2 Diabetic Patients

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ClinicalTrials.gov Identifier: NCT00548808
Recruitment Status : Completed
First Posted : October 24, 2007
Results First Posted : September 15, 2010
Last Update Posted : September 15, 2010
Sponsor:
Information provided by:
Eli Lilly and Company

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Insulin lispro low mixture Drug: Insulin glargine Drug: Insulin lispro Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 426 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 48 weeks ]

Secondary Outcome Measures :
  1. Change in Hemoglobin A1c (HbA1c) Over Time [ Time Frame: Baseline, 16 Weeks, 32 Weeks, 48 Weeks ]
  2. Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time [ Time Frame: 16 weeks, 32 weeks, 48 weeks ]
  3. 7-point Self-monitored Blood Glucose Profiles [ Time Frame: Baseline, 16 weeks, 32 weeks, 48 weeks ]
  4. Change From Baseline in Postprandial Blood Glucose Over Time [ Time Frame: Baseline, 16 weeks, 32 weeks, 48 weeks ]
    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.

  5. Daily Total Insulin Dose (U/Day) at 16, 32, and 48 Weeks [ Time Frame: 16 weeks, 32 weeks, 48 weeks ]
  6. Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks [ Time Frame: 16 weeks, 32 weeks, 48 weeks ]
  7. Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles [ Time Frame: baseline, 48 weeks ]
  8. Safety: Number of Participants With Serious and Non-Serious Adverse Events [ Time Frame: baseline through 48 weeks ]
    Safety was assessed via serious adverse events (SAEs) and AEs, the details of which are listed in the Reported Adverse Event section.



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Ages Eligible for Study:   30 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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)

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): 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

Additional Information:
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 ( Other Identifier: Eli Lilly and Company )
First Posted: October 24, 2007    Key Record Dates
Results First Posted: September 15, 2010
Last Update Posted: September 15, 2010
Last Verified: August 2010

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