Conditions

Diabetes Mellitus, Type 2

Keywords

Metabolic DiseasesDiabetes Mellitus, Type 2GlargineDiabetes MellitusInsulin LISPROInsulin

Outcome Measures

Primary Outcomes (2)

Change in HbA1c From Baseline to 24 Weeks Endpoint (Per Protocol Population)
The change from baseline to 24 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.
Baseline, 24 weeks
Change in HbA1c From Baseline to 24 Weeks Endpoint (Intention-to-Treat Population)
The change from baseline to 24 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.
Baseline, 24 weeks

Secondary Outcomes (12)

Change in the HbA1c Concentration From Baseline to 12 Weeks Endpoint
Baseline, 12 weeks
Number of Participants Who Achieve a Target HbA1c Concentration of Less Than 7% or Less Than or Equal to 6.5% at 24 Weeks
24 weeks
Change in the Fasting Plasma Glucose Concentration From Baseline to 12 Weeks and 24 Weeks
Baseline, 12 weeks, and 24 weeks
7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks
12 weeks, 24 weeks
Glycemic Variability From the 7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks
12 weeks, 24 weeks
+7 more secondary outcomes

Study Arms (2)

Insulin lispro low mixture (LM)

EXPERIMENTAL

Two daily injections (breakfast and dinner) of insulin lispro mix 75/25

Drug: Insulin Lispro Low Mixture (LM)

Insulin glargine+insulin lispro

ACTIVE COMPARATOR

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 GlargineDrug: Prandial Insulin Lispro

Interventions

Insulin Lispro Low Mixture (LM)DRUG

Participant-dependent dose, administered subcutaneously for 24 weeks

Also known as: Humalog Mix75/25 (75% insulin lispro protamine suspension and 25% insulin lispro injection)

Insulin lispro low mixture (LM)

Insulin GlargineDRUG

Participant-dependent dose, administered subcutaneously for 24 weeks

Insulin glargine+insulin lispro

Prandial Insulin LisproDRUG

Participant-dependent dose, administered subcutaneously for 24 weeks

Also known as: Humalog, LY275585

Insulin glargine+insulin lispro

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.