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Completed

NCT Number: NCT00664534

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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., Smiths Falls, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

insulin glargine

Drug

patient glucose-level dependent, injection, as needed per patient glucose level, 48 weeks

Insulin Lispro Premix (mid-mixture and low-mixture)

Drug

patient glucose level dependent, injection, as needed per patient glucose level, 48 weeks

Other names: LY275585

Primary outcomes

  1. Baseline Adjusted Glycosylated Hemoglobin (HbA1c) at Endpoint

    Time frame: 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 outcomes

  1. Percentage of Participants Using Each Possible Final Insulin Regimen

    Time frame: 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.

  2. HbA1c Over Time

    Time frame: 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.

  3. Percentage of Patients Achieving HbA1c Less Than or Equal to 6.5% and Less Than or Equal to 7% Over Time

    Time frame: 16 weeks, 32 weeks and 48 weeks

  4. 7-point Self-monitored Blood Glucose Profiles

    Time frame: 16 weeks, 32 weeks and 48 weeks

  5. Mean Postprandial Blood Glucose Values

    Time frame: 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.

  6. Mean Daily Total, Basal and Prandial Insulin Dose

    Time frame: 16 weeks, 32 weeks and 48 weeks

  7. Body Weight Change From Baseline to Endpoint

    Time frame: baseline, 48 weeks

  8. Incidence of All Self-reported Hypoglycemic Episodes

    Time frame: 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).

  9. Rate Per 30 Days of All Self-reported Hypoglycemic Episodes

    Time frame: 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).

  10. Number of Participants With Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Comparison of Premixed Insulin Lispro Low-Mixture and Mid-Mixture Regimens With Separate Basal and Bolus Insulin Injections in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Oral Therapy Who Consume Light Breakfast

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 23, 2008
Registry last updated
Dec 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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