| April 23, 2008 |
| September 10, 2009 |
| April 2008 |
| October 2009 (final data collection date for primary outcome measure) |
| Insulin Lispro Protamine Suspension provides non-inferior glycemic control to insulin glargine when these basal insulins are injected once daily together with insulin lispro injected 2-3 times daily. [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00666718 on ClinicalTrials.gov Archive Site |
- Change in HbA1c [ Time Frame: 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
- Percentage of patients with HbA1c less than 7.0% and less than or equal to 6.5% [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- 7-point self-monitored blood glucose profiles [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Incidence and rate of all self-reported hypoglycemic episodes [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: Yes ]
- Incidence of treatment-emergent adverse events [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: Yes ]
- Body weight change [ Time Frame: From baseline to 24 weeks ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients |
| 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 |
This study is designed to look at if a basal bolus regimen of insulin lispro protamine suspension 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). |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Diabetes Mellitus, Type 2 |
- Drug: Insulin Glargine
- Drug: Insulin Lispro Protamine Suspension
|
- Active Comparator: Glargine plus Insulin Lispro (2-3 injections) plus metformin
- Experimental: Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin
|
| |
| |
| Active, not recruiting |
| 380 |
| October 2009 |
| October 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Diabetes Mellitus, Type 2
- Have been receiving metformin and at least one other oral antihyperglycemic medication (sulfonylurea or TZD) with insulin for at least 3 months prior to Visit 1
- HbA1c greater than or equal to 7.5% and less than or equal to 11.0%
- BMI greater than or equal to 25 and less than or equal to 45 kg/m2
- 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 an serious disease or any condition considered by the investigator to be exclusionary
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Belgium, Czech Republic, Germany, Greece, Italy, Poland, Romania, Slovakia, Turkey, United Kingdom |
| |
| NCT00666718 |
| Chief Medical Officer, Eli Lilly |
| 12047, F3Z-EW-IOPJ |
| Eli Lilly and Company |
|
| Study Director: |
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) |
Eli Lilly and Company |
|
|
| Eli Lilly and Company |
| September 2009 |
