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OpenTrials
Completed

NCT Number: NCT00548808

A Study for Type 2 Diabetic Patients

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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., Daw Park, South Australia, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Insulin lispro low mixture

Drug

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 names: LY275585[P]

insulin glargine

Drug

Dose depending on patient's need; one daily subcutaneous injection before bedtime for 48 weeks

Insulin Lispro

Drug

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 names: LY275585

Primary outcomes

  1. Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c)

    Time frame: Baseline, 48 weeks

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 24, 2007
Registry last updated
Sep 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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