ClinicalTrials.gov processed this data on March 28, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT000365044050F3Z-MC-IONDNCT00036504Efficacy and Safety of Twice-Daily Insulin Lispro Low Mixture Compared to a Once-Daily Long Acting Insulin Comparator in Patients Who Have Been Using One or More Oral Antihyperglycemic Agents Without InsulinEfficacy and Safety of Twice-Daily Insulin Lispro Low Mixture Compared to a Once-Daily Long Acting Insulin Comparator in Patients New to Insulin Therapy Who Were Inadequately Controlled on Oral AgentsEli Lilly and CompanyIndustry
The purposes of this study are to determine: 1. If patients taking insulin lispro LM with
metformin will have better overall control of their blood sugar than patients taking a long
acting insulin comparator with metformin. 2. If there is a difference in the way the two
treatments affect blood sugar control before and after meals and at night. 3. If there is a
difference in the insulin dose required with the two treatments. 4. If there is a difference
in the numbers of times patients experience low blood sugar with the two treatments. 5. If
there is a difference in the effect on patients's body weight.
The aim of the present study is to compare two treatments - LM twice daily plus metformin two
or three times daily versus a long acting insulin comparator once daily plus metformin two or
three times daily - in patients with type 2 diabetes who are currently using a regimen of one
or more oral antihyperglycemic agents.
The primary objective of this study is to demonstrate that, in patients with type 2 diabetes
who are new to insulin, hemoglobin A1c at endpoint will be lower after treatment with insulin
lispro LM twice daily plus metformin than after treatment with a long acting insulin
comparator once daily plus metformin.
This will be a multicenter, randomized, open-label, crossover study comparing twice-daily
insulin lispro LM plus two- or three-times-daily metformin to a once-daily long acting
insulin comparator plus two- or three-times-daily metformin in patients with type 2 diabetes
who were receiving one or more oral antihyperglycemic agents without insulin prior to the
study.
Following an 8 (+-2) week lead-in period consisting of treatment with NPH once daily at
bedtime plus metformin two or three times daily, approximately 100 eligible patients will be
randomized to one of two sequence groups, so that there are approximately 50 patients in each
group. One group will receive 4 months of insulin lispro LM administered immediately before
the morning and evening meals plus metformin two or three times daily followed by 4 months of
a once-daily long acting insulin comparator at bedtime plus metformin two or three times
daily. The other group will receive the reverse sequence.
CompletedAugust 2001August 2002Phase 4InterventionalRandomizedCrossover AssignmentTreatmentNone (Open Label)100Type 2 Diabetes MellitusDrugInsulin Lispro low mixture
Inclusion Criteria:
- Type 2 diabetes.
- At least 30 years old and less than 80 years old.
- Using oral agents without insulin for 30 days prior ot study.
- Willing to start insulin injections using a pen device.
- Keep a patient diary.
Exclusion Criteria:
- Undergoing therapy for cancers.
- History of renal transplant or receiving renal dialysis.
- Have participated in an interventional medical, surgical, or pharmaceutical study (a
study in which a medical or surgical treatment was given) within 30 days prior to
entry into the study.
- Women who are breastfeeding.
- Have been treated with a drug within the last 30 days that has not received regulatory
approval.
All30 Years79 YearsNoLaJollaCaliforniaUnited StatesWalnut CreekCaliforniaUnited StatesNew BritainConnecticutUnited StatesLongwoodFloridaUnited StatesAtlantaGeorgiaUnited StatesFayettevilleGeorgiaUnited StatesBoiseIdahoUnited StatesSpringfieldIllinoisUnited StatesMt. LaurelNew JerseyUnited StatesNew BrunswickNew JerseyUnited StatesSyracuseNew YorkUnited StatesChattanoogaTennesseeUnited StatesDallasTexasUnited StatesUnited StatesMalone JK, Kerr LF, Campaigne BN, Sachson RA, Holcombe JH; Lispro Mixture-Glargine Study Group. Combined therapy with insulin lispro Mix 75/25 plus metformin or insulin glargine plus metformin: a 16-week, randomized, open-label, crossover study in patients with type 2 diabetes beginning insulin therapy. Clin Ther. 2004 Dec;26(12):2034-44. doi: 10.1016/j.clinthera.2004.12.015. Erratum In: Clin Ther. 2005 Jul;27(7):1112.15823767Hirsch IB, Yuan H, Campaigne BN, Tan MH. Impact of prandial plus basal vs basal insulin on glycemic variability in type 2 diabetic patients. Endocr Pract. 2009 May-Jun;15(4):343-8. doi: 10.4158/EP08308.ORR.19454394Chan JY, Leyk M, Frier BM, Tan MH. Relationship between HbA1c and hypoglycaemia in patients with type 2 diabetes treated with different insulin regimens in combination with metformin. Diabetes Metab Res Rev. 2009 Mar;25(3):224-31. doi: 10.1002/dmrr.929.19156705Shrom D, Sarwat S, Ilag L, Bloomgarden ZT. Does A1c consistently reflect mean plasma glucose? J Diabetes. 2010 Jun;2(2):92-6. doi: 10.1111/j.1753-0407.2010.00066.x. Epub 2010 Jan 22.20923490Sarwat S, Ilag LL, Carey MA, Shrom DS, Heine RJ. The relationship between self-monitored blood glucose values and glycated haemoglobin in insulin-treated patients with Type 2 diabetes. Diabet Med. 2010 May;27(5):589-92. doi: 10.1111/j.1464-5491.2010.02955.x.20536957October 2010May 10, 2002May 10, 2002May 13, 2002October 12, 2010October 12, 2010October 13, 2010Diabetes mellitus, insulin deficiency, hyperglycemiaDiabetes MellitusDiabetes Mellitus, Type 2Insulin Lispro