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Completed

NCT Number: NCT00393705

Lispro Mid Mixture (MM) Intensive Mixture Therapy With Progressive Dose-Titration of Lispro Low Mixture (LM) or Biphasic Insulin Aspart 30/70 (S019)

Investigation into patients with type 2 diabetes mellitus not achieving adequate glycemic control while treated with combination of premixed insulin analogue formulations twice daily and metformin will be randomly assigned to follow one of two insulin treatment strategies used in combination with metformin administration. The aim of the trial is to try to achieve optimal metabolic control and explore full therapeutic potential of the strategies, patients in both arms will follow progressive insulin dose titration algorithms for 16 weeks.

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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

30 year–75 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., Zagreb, Croatia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have type 2 diabetes (World Health Organization [WHO] classification).
  • Are at least 30 years of age and less than 75 years of age.
  • Have been receiving hypoglycemic treatment with premixed insulin analogue (either with insulin lispro LM or biphasic insulin aspart 30/70) administered twice daily in combination with at least 1500 milligrams (mg) of metformin per day for at least 60 days immediately prior to the study.
  • Have a hemoglobin A1c 1.2 to 1.8 times the upper limit of the normal reference range at the local laboratory at Visit 1 or
  • Have at least 6 of 9 of the postprandial blood glucose values recorded in the period between Visit 1 and Visit 2 exceeding 180 milligrams per 100 milliliters (mg/dl) (10.0 millimole per liter [mmol/l]).
  • Have given written informed consent to participate in this study in accordance with local regulations.

Exclusion criteria

  • Are taking any other oral anti-diabetic medication (OAM) not mentioned in inclusion criterion.
  • Have a body mass index greater than 40 kilograms per meter squared (kg/m2).
  • Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.
  • Have congestive heart failure.
  • Have an irregular sleep/wake cycle (for example, patients who sleep during the day and work during the night).

Treatment and study plan

Insulin Biphasic Aspart 30/70

Drug

Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks

insulin lispro LM

Drug

Participant adjusted dose, injected subcutaneously for 16 weeks - possibility of using instead of insulin lispro MM before evening meal if there is a risk of hypoglycemia after the dinner or high fasting glucose levels.

Other names: Low Mix, Humalog

insulin lispro MM

Drug

Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks

Other names: Mid Mix, Humalog

Primary outcomes

  1. Hemoglobin A1c (HbA1c) at 16 Week Endpoint

    Time frame: 16 weeks

Secondary outcomes

  1. Percentage of Patients Achieving Hemoglobin A1c (HbA1c) <7% and HbA1c ≤6.5% at 16 Week Endpoint

    Time frame: 16 weeks

  2. Change From Baseline in Hemoglobin A1c (HbA1c) at 16 Week Endpoint

    Time frame: Baseline, 16 Weeks

  3. 2-hour Postprandial Plasma Glucose Concentrations After the Midday Meal From Self-monitored 7-point Plasma Glucose at 16 Week Endpoint

    Time frame: 16 weeks

    Participants self-monitored their blood glucose concentrations at 7 time points: three premeal and three 2-hour postprandial meal measurements for the morning (breakfast), midday (lunch), and evening (dinner) meals, as well as a 3:00 AM measurement. Results presented here are for the blood glucose concentrations 2-hours after the midday meal at Week 16.

  4. Mean 2-hour Postprandial Blood Glucose Excursions After Midday Meal at 16 Week Endpoint

    Time frame: 16 weeks

    Participants self-monitored their blood glucose concentrations at 7 time points: three premeal and three 2-hour postprandial meal measurements for the morning (breakfast), midday (lunch), and evening (dinner) meals, as well as a 3:00 AM measurement. Results presented here are for the difference (excursion) between midday premeal and 2-hour postprandial midday meal blood glucose concentrations at Week 16.

  5. Mean Daily Blood Glucose Values at 16 Week Endpoint

    Time frame: 16 weeks

  6. Number of Patients With Self-reported Hypoglycemic Episodes

    Time frame: Baseline through 16 weeks

    Hypoglycemia: any time a patient feels, or another person observes, that patient is experiencing a sign/symptom that he or she would associate with hypoglycemia or a plasma-equivalent glucose measurement ≤70 mg/dL. Nocturnal hypoglycemia: hypoglycemia occurring after bedtime and prior to morning meal and morning dose of insulin or metformin. Severe hypoglycemia: hypoglycemia where patient requires assistance from another person and which is associated with either a blood glucose level less than 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration.

  7. 30-Day Adjusted Rate of Hypoglycemic Events

    Time frame: Baseline through 16 weeks

    Hypoglycemia: any time a patient feels, or another person observes, that patient is experiencing a sign/symptom that he or she would associate with hypoglycemia or a plasma-equivalent glucose measurement ≤70 mg/dL. Nocturnal hypoglycemia: hypoglycemia occurring after bedtime and prior to morning meal and morning dose of insulin or metformin. Severe hypoglycemia: hypoglycemia where patient requires assistance from another person and which is associated with either a blood glucose level less than 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration.

  8. Change From Baseline in Weight at 16 Week Endpoint

    Time frame: Baseline, 16 weeks

  9. Total Daily Insulin Dose at 4 Weeks and 12 Weeks

    Time frame: 4 weeks and 12 weeks

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Comparison of Insulin Lispro MM Intensive Mixture Therapy With Progressive Dose-Titration of Insulin Lispro LM or Biphasic Insulin Aspart 30/70

Acronym: S019

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Oct 30, 2006
Registry last updated
Jul 20, 2010

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

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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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