Comparison of the Efficacy and Safety of Two Insulin Intensification Strategies
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01175824
First received: August 3, 2010
Last updated: December 6, 2012
Last verified: December 2012
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Purpose
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 patients with Type 2 Diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Insulin Lispro Drug: Insulin Glargine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of Twice-Daily Insulin Lispro Low Mixture Versus Once-Daily Basal Insulin Glargine and Once-Daily Prandial Insulin Lispro as Insulin Intensification Strategies in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Glargine and Metformin and/or Pioglitazone |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Change in HbA1c from baseline to 24 weeks endpoint [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in the HbA1c concentration from baseline to 12 weeks endpoint [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
- Proportion of patients who achieve a target HbA1c concentration of less than7% or less than or equal to 6.5% at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Change in the fasting plasma glucose concentration from baseline to 12 weeks and 24 weeks [ Time Frame: Baseline, 12 weeks, and 24 weeks ] [ Designated as safety issue: No ]
- 7-point self-monitored blood glucose (SMBG) profiles at 12 weeks and 24 weeks [ Time Frame: 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
- Glycemic variability from the 7-point SMBG profiles at 12 weeks and 24 weeks [ Time Frame: 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
- Daily insulin dose: total, basal, and prandial at 12 weeks and 24 weeks [ Time Frame: 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
- Change in weight from baseline to 12 weeks and 24 weeks [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
- The incidence of hypoglycemic episodes [ Time Frame: over 24 weeks ] [ Designated as safety issue: Yes ]
- Insulin Treatment Satisfaction Questionnaire (ITSQ) score at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Perceptions about Medications-Diabetes 21 (PAM-D21) questionnaire score at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- The rate of hypoglycemic episodes [ Time Frame: over 24 weeks ] [ Designated as safety issue: Yes ]
- The severity of hypoglycemic episodes [ Time Frame: over 24 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 478 |
| Study Start Date: | April 2011 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Insulin lispro low mixture
Two daily injections (breakfast and dinner) of insulin lispro mix 75/25
|
Drug: Insulin Lispro
Patient dependent dose, administered subcutaneously for 24 weeks
Other Names:
|
|
Active Comparator: Insulin glargine+insulin lispro
Once-daily (bedtime) basal insulin glargine and once-daily (before the main meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro
|
Drug: Insulin Lispro
Patient dependent dose, administered subcutaneously for 24 weeks
Other Names:
Drug: Insulin Glargine
Patient dependent dose, administered subcutaneously for 24 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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 mmol/L (less than or equal to 121 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 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175824
Locations
| Argentina | |
| 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. | |
| Mar Del Plata, Argentina, B7600FZN | |
| 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. | |
| Ramos Mejia, Argentina, B1704ETD | |
| Brazil | |
| 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. | |
| Porto Alegre, Brazil, 90035-170 | |
| 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. | |
| São Paulo, Brazil, 01244-030 | |
| China | |
| 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. | |
| Changzhou, China, 213003 | |
| 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. | |
| Harbin, China, 150086 | |
| Egypt | |
| 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. | |
| Alexandria, Egypt | |
| 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. | |
| Cairo, Egypt, 11562 | |
| India | |
| 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. | |
| Jaipur, India, 302018 | |
| 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. | |
| Vishakhapatnam, India, 530002 | |
| Korea, Republic of | |
| 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. | |
| Daegu, Korea, Republic of, 700-712 | |
| 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. | |
| Goyang-Si, Korea, Republic of, 410-719 | |
| 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. | |
| Kyunggi-Do, Korea, Republic of, 425-020 | |
| 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. | |
| Seoul, Korea, Republic of, 134-090 | |
| Spain | |
| 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. | |
| Málaga, Spain, 29010 | |
| 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. | |
| San Boi De Llobregat, Spain, 08830 | |
| Turkey | |
| 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. | |
| Antalya, Turkey, 07070 | |
| 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. | |
| Istanbul, Turkey, 34865 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT01175824 History of Changes |
| Other Study ID Numbers: | 13493, F3Z-CR-IOQE |
| Study First Received: | August 3, 2010 |
| Last Updated: | December 6, 2012 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Brazil: Ministry of Health Egypt: Ministry of Health, Drug Policy and Planning Center India: Drugs Controller General of India Korea: Food and Drug Administration Romania: National Medicines Agency Russia: Ministry of Health of the Russian Federation Spain: Ministry of Health Turkey: Ministry of Health China: Food and Drug Administration |
Keywords provided by Eli Lilly and Company:
|
Metabolic Diseases Diabetes Mellitus, Type 2 Glargine |
Diabetes Mellitus Insulin LISPRO Insulin |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin LISPRO |
Glargine Insulin Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013