Phase 4
Completed N=478
Comparison of the Efficacy and Safety of Two Insulin Intensification Strategies
Source: ClinicalTrials.gov NCT01175824 ↗Enrolled (actual)
478
Serious AEs
4.0%
Results posted
Feb 2014
Primary outcomePrimary: Change in HbA1c From Baseline to 24 Weeks Endpoint (Per Protocol Population) — -1.30; -1.09 percentage of HbA1c
Summary
The study is a comparison of twice-daily insulin lispro low mixture versus once-daily basal insulin glargine and once-daily prandial insulin lispro, in participants with Type 2 Diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to 24 Weeks Endpoint (Per Protocol Population) |
-1.30; -1.09 | — |
| PRIMARY Change in HbA1c From Baseline to 24 Weeks Endpoint (Intention-to-Treat Population) |
-1.30; -1.08 | — |
| SECONDARY Change in the HbA1c Concentration From Baseline to 12 Weeks Endpoint |
-1.12; -1.01 | 0.1858 |
| SECONDARY Number of Participants Who Achieve a Target HbA1c Concentration of Less Than 7% or Less Than or Equal to 6.5% at 24 Weeks |
76; 66; 36; 31 | 0.3588 |
| SECONDARY Change in the Fasting Plasma Glucose Concentration From Baseline to 12 Weeks and 24 Weeks |
1.04; 0.64; 0.89; 0.75 | 0.0827 |
| SECONDARY 7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks |
6.87; 6.20; 8.82; 9.01; 6.96; 7.44 | — |
| SECONDARY Glycemic Variability From the 7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks |
2.12; 2.13; 2.03; 1.99 | — |
| SECONDARY Daily Insulin Dose: Total, Basal, and Prandial at 12 Weeks and 24 Weeks |
51.2; 49.2; 53.1; 50.8; 38.4; 37.1 | — |
| SECONDARY Change in Weight From Baseline to 12 Weeks and 24 Weeks |
0.54; 0.34; 1.13; 0.50 | 0.2833 |
| SECONDARY The Number of Participants With a Hypoglycemic Episodes (Incidence) |
144; 150 | — |
| SECONDARY Insulin Treatment Satisfaction Questionnaire (ITSQ) Score at 24 Weeks |
80.91; 81.84 | — |
| SECONDARY Perceptions About Medications-Diabetes 21 (PAM-D21) Questionnaire Score at 24 Weeks |
83.90; 84.13; 76.78; 78.76; 81.84; 81.86 | — |
| SECONDARY The Rate of Hypoglycemic Episodes |
1.07; 1.36 | — |
| SECONDARY The Number of Participants With Severe Hypoglycemic Episodes |
2; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Present with type 2 diabetes mellitus
- Have been taking metformin and/or pioglitazone
- Have received treatment with basal insulin glargine, injected once a day, for greater than or equal to 90 days
- Have glycosylated hemoglobin A1c (HbA1c) concentration between greater than or equal to 7.5% and less than or equal to 10.5
- Have a fasting plasma glucose concentration of less than or equal to 6.7 millimoles per liter [mmol/L, less than or equal to 121 milligrams per deciliter (mg/dL)], or greater than 6.7 mmol/L (greater than 121 mg/dL) if the investigator considers that further titration of basal insulin glargine is not possible for safety reasons
- Not pregnant or breastfeeding
Exclusion Criteria
- Have Type 1 Diabetes
- Their stable dose of pioglitazone is greater than the maximum dose approved for use in combination with insulin in their country
- Have a body mass index (BMI) greater than 45 kilograms per square meter (kg/m2).
- Have a history of scheduled mealtime (prandial) insulin use within 12 weeks of the screening visit and the total duration of the prandial insulin treatment was greater than 2 weeks
- Have had more than one episode of severe hypoglycaemia within 24 weeks prior to entry into the study
- Have cardiac disease with a functional status that is Class III or IV
- Have a history of renal or liver disease
- Have had a blood transfusion or have a blood disorder
Data sourced from ClinicalTrials.gov (NCT01175824). 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.