Phase 3
Completed N=387
Comparison of Two Basal Insulin Therapies for Patients With Type 1 Diabetes
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT00487240 ↗
Enrolled (actual)
387
Serious AEs
—
Results posted
Sep 2009
Primary outcomePrimary: Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint — 8.88; 8.68; -0.69; -0.59 percent of HbA1c — p=0.332
Summary
The purpose of this study is to examine the efficacy and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin combined with mealtime insulin therapy in patients with type 1 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint |
8.88; 8.68; -0.69; -0.59 | 0.332 |
| SECONDARY Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values |
8.88; 8.68; 8.08; 8.11; -0.68; -0.64 | 0.718 |
| SECONDARY Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5% |
18.5; 18.7; 81.5; 81.3; 15.2; 15.4 | 1.000 |
| SECONDARY 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint |
8.67; 8.48; 8.77; 8.56; 8.70; 8.58 | 0.259 |
| SECONDARY Glycemic Variability at Endpoint |
2.64; 2.30; 36.39; 32.19; 3.04; 2.78 | 0.132 |
| SECONDARY Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint |
134; 135; 173; 173; 69; 55 | 0.737 |
| SECONDARY 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint |
66.41; 52.60; 76.45; 61.21; 8.90; 5.60 | 0.280 |
| SECONDARY 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint |
5.45; 4.32; 6.28; 5.03; 0.73; 0.46 | — |
| SECONDARY Change From Baseline in Absolute Body Weight at 32 Week Endpoint |
72.76; 72.69; 1.54; 0.58 | 0.003 sig |
| SECONDARY Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus]) |
0.91; 0.99; 0.39; 0.45; 0.53; 0.55 | 0.023 sig |
| SECONDARY Insulin Dose (Total and By Component [Basal and Bolus]) |
67.78; 73.84; 28.94; 33.32; 38.99; 40.70 | 0.82 |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of type 1 diabetes for one year or more
- Age 18 years or older
- Body mass index (BMI) less than or equal to 35 kilograms per square meter (kg/m2)
- Have a hemoglobin A1c (HbA1c) 1.2 to 2.0 times the upper limit of the normal (ULN) reference range within 30 days prior to Visit 1 or collected and analyzed at a local laboratory at Visit 1
- As determined by the investigator, are capable and willing to do the following:
- perform self monitoring of blood glucose (SMBG),
- complete patient diaries as required for this protocol,
- use the insulin injection device(s) according to the instructions provided,
- are receptive to diabetes education,
- comply with the required study visits.
Exclusion Criteria
- Have taken any oral antihyperglycemic medications (OAMs) within 3 months prior to Visit 1.
- Have had more than one episode of severe hypoglycemia, as defined in the Abbreviations and Definitions section of the protocol, within 6 months prior to entry into the study
- Are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable or women who are breastfeeding
- Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, intraocular, and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding Visit 1.
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Data sourced from ClinicalTrials.gov (NCT00487240). 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.