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OpenTrials
Completed

NCT Number: NCT00666718

A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients

This study is designed to look at if a basal bolus regimen of insulin lispro protamine suspension (ILPS) provides the same glycemic control as a basal bolus regimen of insulin glargine (when one basal bolus regimen is injected once daily together with insulin lispro injected 2-3 times daily).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

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., Genk, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diabetes Mellitus, Type 2
  • Have been receiving metformin and at least one other oral antihyperglycemic medication (sulfonylurea or thiazolidinedione) with insulin for at least 3 months prior to Visit 1 (Screening)
  • Hemoglobin A1C (HbA1c) greater than or equal to 7.5% and less than or equal to 11.0%
  • Body Mass Index (BMI) greater than or equal to 25 and less than or equal to 45 kg/m^2
  • Capable and willing to follow the protocol
  • Give written consent

Exclusion criteria

  • Are taking any glucose-lowering agents (other than those listed in the inclusion criteria above)
  • Have a history of severe hypoglycemia in the past 6 months
  • Are pregnant or may become pregnant
  • Women who are breastfeeding
  • Have significant cardiac disease
  • Have significant renal or liver disease
  • Undergoing therapy for a malignancy
  • Contraindications to the study medications
  • Have an irregular sleep/wake cycle
  • Have a serious disease or any condition considered by the investigator to be exclusionary

Treatment and study plan

insulin glargine

Drug

patient glucose-level dependent, injection, once daily in the evening, 24 weeks

Insulin Lispro Protamine Suspension (ILPS)

Drug

patient glucose-level dependent, injection, once daily in the evening, 24 weeks

Other names: LY275585

Insulin Lispro

Drug

subcutaneous injections prior to meals, 24 weeks

Primary outcomes

  1. Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24

    Time frame: Baseline, Week 24

    Least Squares Mean (LSMean) values reported in the table were controlled for treatment, country, and baseline HbA1c value.

Secondary outcomes

  1. Change From Baseline in HbA1c at Week 12 and Week 24

    Time frame: Baseline, Week 12, Week 24

    LSMean values presented were controlled for treatment, country, baseline HbA1C value and week.

  2. Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint

    Time frame: Week 24

  3. 7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint

    Time frame: 24 weeks

    LSMean values presented were controlled for treatment, country, and baseline HbA1C value. SMBG at morning pre-meal, morning postprandial, midday pre-meal, midday postprandial, evening pre-meal, evening postprandial, 0300 hours. Postprandial glucose is measured 2 hours after the start of the meal.

  4. Glycemic Variability at Endpoint

    Time frame: Week 24

    LSMeans were controlled for treatment and country grouping (Mediterranean, rest of Europe). Glycemic variability was assessed as the standard deviations of 4 fasting SMBG samples, 4 post-breakfast measurements, 4 post-lunch measurements, 4 post-evening meal measurements.

  5. Rate Of All Self-reported Hypoglycemic Episodes

    Time frame: Baseline through Week 24

    Rate of self-reported hypoglycemic episodes, all, non-nocturnal,and nocturnal, severe, documented ≤3.9 mmol/L and ≤3.0 mmol/L. Rate=episodes/30 days/patient/. Episode=any time a patient has a symptom associated with hypoglycemia or blood glucose level of ≤70 mg/dL,even if not associated with symptoms.Overall=any time post-randomization in the study period. Nocturnal=Episode between bedtime and waking. Non-Nocturnal=Episode between waking and bedtime.Severe:episode in which patient requires assistance,and has glucose <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or IV glucose.

  6. Percentage of Participants With Self-Reported Hypoglycemic Episodes

    Time frame: Baseline through Week 24

    Episode=any time a patient feels that he/she is experiencing a sign or symptom associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if not associated with signs,symptoms, or treatment. Overall=any time post-randomization visits in the study period. Nocturnal=Episode that occurs between bedtime and waking. Non-Nocturnal=Episode occurring between waking and bedtime. Severe=episode with symptoms of neuroglycopenia in which patient requires assistance,and has blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.

  7. Number of Participants With Adverse Events (AE)

    Time frame: Baseline through Week 24

    A listing of adverse events is located in the Reported Adverse Event module.

  8. Change in Body Weight From Baseline to Week 24

    Time frame: Baseline, Week 24

    LSMean values presented were controlled for treatment, country, and baseline HbA1C value.

  9. Total Daily Insulin Dose at Endpoint

    Time frame: Week 24

    LSMean values presented were controlled for treatment, country, and baseline HbA1C value.

  10. Number of Injections of Insulin at Week 24

    Time frame: Week 24

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Prospective Randomized Trial to Compare Basal Bolus Therapies That Use Either Insulin Lispro Protamine Suspension or Insulin Glargine Together With Lispro Insulin in Patients With Type 2 Diabetes

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 25, 2008
Registry last updated
May 13, 2011

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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