Phase 4
Completed N=302
Lispro Mid Mixture (MM) Intensive Mixture Therapy With Progressive Dose-Titration of Lispro Low Mixture (LM) or Biphasic Insulin Aspart 30/70 (S019)
Source: ClinicalTrials.gov NCT00393705 ↗Enrolled (actual)
302
Serious AEs
3.6%
Results posted
Apr 2010
Primary outcomePrimary: Hemoglobin A1c (HbA1c) at 16 Week Endpoint — 7.71; 7.84 percent HbA1c — p=0.2519
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1c (HbA1c) at 16 Week Endpoint |
7.71; 7.84 | 0.2519 |
| SECONDARY Percentage of Patients Achieving Hemoglobin A1c (HbA1c) <7% and HbA1c ≤6.5% at 16 Week Endpoint |
21.4; 18.5; 11.5; 6.7 | 0.0287 sig |
| SECONDARY Change From Baseline in Hemoglobin A1c (HbA1c) at 16 Week Endpoint |
-1.00; -0.82 | — |
| SECONDARY 2-hour Postprandial Plasma Glucose Concentrations After the Midday Meal From Self-monitored 7-point Plasma Glucose at 16 Week Endpoint |
163.4; 178.2 | 0.0077 sig |
| SECONDARY Mean 2-hour Postprandial Blood Glucose Excursions After Midday Meal at 16 Week Endpoint |
17.0; 36.1 | 0.0002 sig |
| SECONDARY Mean Daily Blood Glucose Values at 16 Week Endpoint |
161.1; 153.9; 179.0; 160.9; 146.3; 141.7 | 0.0129 sig |
| SECONDARY Number of Patients With Self-reported Hypoglycemic Episodes |
24; 14; 9; 11; 24; 33 | — |
| SECONDARY 30-Day Adjusted Rate of Hypoglycemic Events |
0.52; 0.64; 0.04; 0.12; 0.01; 0 | 0.7230 |
| SECONDARY Change From Baseline in Weight at 16 Week Endpoint |
1.3; 0.4 | 0.0009 sig |
| SECONDARY Total Daily Insulin Dose at 4 Weeks and 12 Weeks |
57.1; 51.4; 64.4; 58.0 | 0.0056 sig |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT00393705). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.