Diabetes Mellitus, Type 2 Clinical Trial
— IOOVOfficial title:
The Durability of Twice-Daily Insulin Lispro Low Mixture Compared to Once-Daily Insulin Glargine When Added to Existing Oral Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control
This study will compare insulin lispro low mixture [LM] and insulin glargine both in
combination with the patient's oral diabetes medicines, for their ability to control blood
sugar in patients with type 2 diabetes and compare insulin lispro LM to insulin glargine
with regard to the length of time that the overall blood sugar can be controlled.
This study will also determine whether the safety of insulin lispro LM and any side effects
that might be associated with it are different from those observed with insulin glargine,
both in combination with the patient's oral diabetes medications.
The addendum study (Intensification Addendum) will compare how different insulin treatments
work to control blood sugar in patients whose diabetes could not be controlled by either
insulin lispro LM or insulin glargine.
| Status | Completed |
| Enrollment | 2091 |
| Est. completion date | November 2009 |
| Est. primary completion date | November 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years to 79 Years |
| Eligibility |
Inclusion Criteria: - Must have type 2 diabetes. - Must be at least 30 and less than 80 years of age at the time of Visit 1. - Must be on at least two oral antidiabetes medications for at least 90 days. - Must have an HbA1c 1.2 to 2.0 times the upper limit of normal reference range at the local lab. Exclusion Criteria: - Must not have used insulin on a regular basis in the last 12 months. - Must not have had more than one episode of severe hypoglycemia in the last 24 weeks. - Must not have a body mass index (BMI) of greater than 45 (morbid obesity). - Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease. - Must not be pregnant or intend to get pregnant during course of the study. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| 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. | Buenos Aires | |
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| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Argentina, Australia, Brazil, Canada, Greece, Hungary, India, Netherlands, Puerto Rico, Romania, Spain,
Fahrbach J, Jacober S, Jiang H, Martin S. The DURABLE trial study design: comparing the safety, efficacy, and durability of insulin glargine to insulin lispro mix 75/25 added to oral antihyperglycemic agents in patients with type 2 diabetes. J Diabetes Sc — View Citation
Herman WH, Dungan KM, Wolffenbuttel BH, Buse JB, Fahrbach JL, Jiang H, Martin S. Racial and ethnic differences in mean plasma glucose, hemoglobin A1c, and 1,5-anhydroglucitol in over 2000 patients with type 2 diabetes. J Clin Endocrinol Metab. 2009 May;94 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c) | Endpoint (Initiation: Week 24) | No | |
| Primary | MAINTENANCE: Duration of Time HbA1c Maintained at Goal by Initiation Regimen (Insulin Glargine or Lispro Low Mix) | HbA1c goal: HbA1c =7.0% or HbA1c >7.0% but increased <0.4% from last HbA1c =7.0% | Endpoint (Last Observation Carried Forward [LOCF]) (Maintenance: up to 2.5 years) | No |
| Primary | ADDENDUM: 24-Week Endpoint HbA1c | HbA1c at 24-week endpoint in Intensification Addendum of the trial. | Endpoint (Addendum) (24 weeks: Week 48) | No |
| Secondary | INITIATION: Change in HbA1c From Baseline to 24 Weeks | Baseline (Initiation) to Endpoint (LOCF, Week 24) | No | |
| Secondary | INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint | Endpoint (Initiation: Week 24) | No | |
| Secondary | INITIATION: HbA1c | Baseline (Initiation), Week 12, Week 24, Endpoint (LOCF) | No | |
| Secondary | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose. | Endpoint (LOCF) (Initiation: Week 24) | No |
| Secondary | INITIATION: Change From Baseline to Endpoint in 1,5 Anhydroglucitol (1,5 AG) | Baseline (Initiation), Endpoint (Week 24) | No | |
| Secondary | INITIATION: Incremental Change From Baseline in Body Weight | Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF) | Yes | |
| Secondary | INITIATION: Body Weight | Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF) | Yes | |
| Secondary | INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes | Hypoglycemia = any time participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement =70 mg/dL (=3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia. | Baseline (Initiation), Endpoint (Week 24), Overall (sum of frequencies of hypoglycemic episodes after baseline ([Week 0]). | Yes |
| Secondary | INITIATION: Rate of Self-reported Hypoglycemic Episodes | Hypoglycemia = participant feels/person observes, that participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or glucose measurement =70 mg/dL (=3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia. | Endpoint (Initiation: Week 24), Overall (incidence of hypoglycemic episodes after baseline [Week 0]) | Yes |
| Secondary | INITIATION: Insulin Dose | Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, Endpoint (LOCF) | No | |
| Secondary | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Age | Comparison of age at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c =7.0%). | Endpoint (Initiation: Week 24) | No |
| Secondary | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin | Comparison of origin at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c =7.0%). | Endpoint (Initiation: Week 24) | No |
| Secondary | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Comparison of HOMA-IR (surrogate markers of insulin resistance calculated from fasting insulin and glucose) at baseline between those participants who met their goal at Week 24 and those who did not meet their goal at Week 24 (goal HbA1c =7.0%). HOMA-IR = fasting insulin (milliunits per milliliter) * fasting plasma glucose (millimoles per liter) / 22.5. | Endpoint (Initiation: Week 24) | No |
| Secondary | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - HbA1c | Comparison of baseline HbA1c between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c =7.0%). | Endpoint (Initiation: Week 24) | No |
| Secondary | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Baseline HbA1c Percentage Group | Comparison of baseline HbA1c percentage group (<8.5,>=8.5) between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c =7.0%). | Endpoint (Initiation: Week 24) | No |
| Secondary | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - 1,5 AG | Comparison of 1,5 AG between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c =7.0%). | Endpoint (Initiation: Week 24) | No |
| Secondary | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose | Comparison of pre meals blood glucose, post meals blood glucose, average of all blood glucose, and fasting blood glucose between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c =7.0%). | Endpoint (Initiation: Week 24) | No |
| Secondary | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline | Comparison of oral diabetes medication at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c =7.0%). | Endpoint (Initiation: Week 24) | No |
| Secondary | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Baseline (Week 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (up to 2.5 years) | No | |
| Secondary | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose. | Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years) | No |
| Secondary | MAINTENANCE: Rate of Increase in HbA1c | Rate of increase: HbA1c change/time period (month). | Endpoint (LOCF) (Maintenance: up to 2.5 years) | No |
| Secondary | MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5% | Endpoint (LOCF) (Maintenance: up to 2.5 years) | No | |
| Secondary | MAINTENANCE: Incremental Change From Baseline in Body Weight | Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years) | Yes | |
| Secondary | MAINTENANCE: Body Weight | Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years) | Yes | |
| Secondary | MAINTENANCE: Insulin Dose | Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years) | No | |
| Secondary | MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes | Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement =70 mg/dL (=3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia. | Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline (Week 0) | Yes |
| Secondary | MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes | Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement =70 mg/dL (=3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia. | Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline [Week 0]) | Yes |
| Secondary | MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol | Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years) | No | |
| Secondary | MAINTENANCE: Change From Baseline to Endpoint in HbA1c | Baseline (Week 0), Week 24, Endpoint (LOCF) (Maintenance) (up to 2.5 years) | No | |
| Secondary | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes | Comparison of duration of diabetes at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%. | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | No |
| Secondary | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes | Comparison of duration of diabetes at baseline between those participants taking lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%. | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | No |
| Secondary | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group | Comparison of duration of diabetes group (<10, 10-<20, >=20 years) at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%. | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | No |
| Secondary | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group | Comparison of duration of diabetes group (<10, 10-<20, >=20 years) at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%. | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | No |
| Secondary | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c | Comparison of baseline HbA1c between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%. | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | No |
| Secondary | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c | Comparison of baseline HbA1c between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%. | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | No |
| Secondary | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group | Comparison of baseline HbA1c group (<8.5,>=8.5) between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%. | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | No |
| Secondary | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group | Comparison of baseline HbA1c group (<8.5,>=8.5) between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%. | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | No |
| Secondary | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline | Comparison of oral diabetes medication at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%. | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | No |
| Secondary | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline | Comparison of oral diabetes medication at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%. | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | No |
| Secondary | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG | Comparison of baseline 1,5 AG between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%. | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | No |
| Secondary | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG | Comparison of baseline 1,5 AG between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%. | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | No |
| Secondary | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose | Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%. | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | No |
| Secondary | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose | Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%. | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | No |
| Secondary | ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint | Baseline (Addendum: Week 24), Endpoint (24 weeks [Week 48]) | No | |
| Secondary | ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5% | Endpoint (Addendum: 24 weeks [Week 48]) | No | |
| Secondary | ADDENDUM: 7-point SMPG Profiles | Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose. | Endpoint (Addendum: 24 weeks [Week 48]) | No |
| Secondary | ADDENDUM: Incremental Change From Baseline in Body Weight | Baseline (Addendum: Week 24), Weeks 6 (30 Weeks), 12 (36 Weeks), 24 (48 Weeks), Endpoint (LOCF) | Yes | |
| Secondary | ADDENDUM: Body Weight | Baseline (Addendum Week 24), Weeks 6 (30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF) | Yes | |
| Secondary | ADDENDUM: Insulin Dose | Baseline (Addendum: Week 24), Weeks 1 (25 weeks), 2 (26 weeks), 3 (27 weeks), 4 (28 weeks), 5 (25 weeks), 6 (26 weeks), 8 (32 weeks), 10 (34 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF) | No | |
| Secondary | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Hypoglycemia = any time participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement =70 mg/dL (=3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia. | Weeks 6 (Addendum: 30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF) | Yes |
| Secondary | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Hypoglycemia = participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement =70 mg/dL (=3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia. | Endpoint (Addendum 24 weeks), Overall (mean yearly rate of hypoglycemia during addendum phase | Yes |
| Secondary | ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24 | Baseline (addendum: 24 weeks), Endpoint (24 weeks: Week 48) | No | |
| Secondary | ADDENDUM: HbA1c at Specified Visits and Endpoint | Baseline (Addendum: 24 weeks), Weeks 12, 24, Endpoint (24 weeks: Week 48) | No |
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