Pre-Mix Insulin Lispro Treatment for Type 2 Diabetes Patients Who Consume a Light Breakfast

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Insulin Lispro Premix (mid-mixture and low-mixture); Drug: Insulin Glargine

• Registration Number: NCT00664534
• Lead Sponsor: Eli Lilly and Company

Brief Summary

This study is designed to look at how best to start and then gradually intensify (as needed) the insulin lispro premix regimen in type 2 diabetes patients who consume a light breakfast.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-21
• Study First Submitted QC: 2008-04-21
• Study First Posted: 2008-04-23
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-11
• Results First Submitted: 2011-11-09
• Results First Submitted QC: 2011-11-09
• Last Update Submitted: 2011-11-09
• Results First Posted: 2011-12-13
• Last Update Posted: 2011-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 344

Inclusion Criteria

• Diabetes Mellitus, Type 2
• have been receiving metformin plus at least one other oral antihyperglycemic medication (OAM) (sulfonylurea or Thiazolidinedione [TZD]) without insulin, for at least 90 days prior to Visit 1
• glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than 11.0%
• regularly consume a light breakfast (less than 15% of total daily calorie intake)
• capable and willing to follow the protocol
• give written consent

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Exclusion Criteria

• are taking a TZD whose country label does not allow in combination with insulin
• are taking any glucose-lowering agents (other than specified in the inclusion criteria above)
• have a body mass index greater than 40 kg/m^2
• have a history of severe hypoglycemia in past 24 weeks
• 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 study medications
• have an irregular sleep/wake cycle

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Premixed Insulin Lispro	Insulin Lispro Premix (mid-mixture and low-mixture)	Premixed Insulin Lispro (mid-mixture or low-mixture) 1,2 or 3 injections plus OAMs
Glargine	Insulin Glargine	Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)

Primary Outcome Measures

Name	Time	Method
Baseline Adjusted Glycosylated Hemoglobin (HbA1c) at Endpoint	48 weeks	Least Squares Mean (LSMean) values were adjusted based on a fixed effect linear regression model: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) in per-protocol (PP) population.

Secondary Outcome Measures

Name	Time	Method
7-point Self-monitored Blood Glucose Profiles	16 weeks, 32 weeks and 48 weeks
Body Weight Change From Baseline to Endpoint	baseline, 48 weeks
Percentage of Patients Achieving HbA1c Less Than or Equal to 6.5% and Less Than or Equal to 7% Over Time	16 weeks, 32 weeks and 48 weeks
Incidence of All Self-reported Hypoglycemic Episodes	Baseline to 48 weeks	Percentage of participants with self-reported hypoglycemic episodes at any time during the study. A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a blood glucose level of ≤70 mg/dL (3.9 mmol/L) (Roche plasma glucose) or ≤75 mg/dL (4.2 mmol/L) (IFCC Plasma Values), even if it was not associated with signs, symptoms, or treatment consistent with current guidelines (ADA 2005).
Rate Per 30 Days of All Self-reported Hypoglycemic Episodes	Baseline to 48 weeks	The hypoglycemia rate between two visits will be calculated as the total number of episodes between the two visits divided by the number of days between the visits, and then multiplied by 30 days (rate per patient per 30 days).
Number of Participants With Adverse Events	Baseline to 48 weeks	A summary of serious adverse events (SAEs) and all other non-serious treatment-emergent adverse events (TEAE) is located in the Reported Adverse Event Module.; TEAEs are defined as events that are newly reported after randomization or reported to worsen in severity from baseline.
Percentage of Participants Using Each Possible Final Insulin Regimen	48 weeks	Insulin Regimens: Lispro: Mid-Mix (MM) before noon; Low-Mix (LM) before evening (PM); MM before noon+LM before PM; LM before morning (AM)+MM before noon + LM before PM; MM before AM +MM before noon+LM before PM Glargine: Glargine once a day (QD); Glargine QD + 1 Lispro (noon or PM); Glargine QD + 2 Lispro (noon and PM); Glargine QD + 3 Lispro.
HbA1c Over Time	16 weeks, 32 weeks, and 48 weeks	Least Squares Mean (LSMean) values were adjusted based on a mixed effect linear regression model with a participant specific random effect: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) + visit + visit\*treatment in Full Analysis Set (FAS) Population.
Mean Postprandial Blood Glucose Values	Baseline, 16 weeks, 32 weeks and 48 weeks	Mean postprandial blood glucose values were assessed using GlycoMark, which is an FDA-approved blood test measuring levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma. When 1,5 AG values decrease, serum glucose levels increase.
Mean Daily Total, Basal and Prandial Insulin Dose	16 weeks, 32 weeks and 48 weeks

Trial Locations

Locations (1)

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.; 🇹🇷 Konya, Turkey