Phase 4 Completed N=2,091 Randomized Treatment

The DURABLE Trial: Evaluating the Durability of Starter Insulin Regimens in Patients With Type 2 Diabetes (IOOV)

Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov NCT00279201 ↗

Enrolled (actual)

2,091

Serious AEs

6.5%

Results posted

Feb 2011

Primary outcomePrimary: INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c) — 7.33; 7.23 percent glycosylated hemoglobin — p=0.005

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c)	7.33; 7.23	0.005 sig
PRIMARY MAINTENANCE: Duration of Time HbA1c Maintained at Goal by Initiation Regimen (Insulin Glargine or Lispro Low Mix)	14.40; 16.80	0.040 sig
PRIMARY ADDENDUM: 24-Week Endpoint HbA1c	8.19; 8.03; 8.16; 8.14	0.271
SECONDARY INITIATION: Change in HbA1c From Baseline to 24 Weeks	-1.68; -1.83	0.005 sig
SECONDARY INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint	45.8; 52.5; 40.3; 47.5; 22.2; 24.6	0.002 sig
SECONDARY INITIATION: HbA1c	9.02; 9.06; 7.42; 7.27; 7.28; 7.19	0.416
SECONDARY INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions	196.16; 192.91; 121.52; 133.54; 251.45; 252.46	0.179
SECONDARY INITIATION: Change From Baseline to Endpoint in 1,5 Anhydroglucitol (1,5 AG)	4.61; 5.25	0.003 sig
SECONDARY INITIATION: Incremental Change From Baseline in Body Weight	0.97; 1.66; 1.60; 2.63; 2.24; 3.44	<0.001 sig
SECONDARY INITIATION: Body Weight	88.23; 88.84; 89.24; 90.63; 89.80; 91.79	0.497
SECONDARY INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes	51.8; 57.1; 76.7; 80.5; 34.3; 33.9	0.016 sig
SECONDARY INITIATION: Rate of Self-reported Hypoglycemic Episodes	11.42; 8.86; 9.80; 9.22; 0.02; 0.09	0.009 sig
SECONDARY INITIATION: Insulin Dose	0.13; 0.24; 0.18; 0.28; 0.23; 0.32	<0.001 sig
SECONDARY INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Age	58.21; 55.85	<0.001 sig
SECONDARY INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin	680; 521; 50; 44; 11; 28	<0.001 sig
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)	4.44; 5.45	<0.001 sig
SECONDARY INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - HbA1c	8.66; 9.40	<0.001 sig
SECONDARY INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Baseline HbA1c Percentage Group	464; 220; 451; 665	<0.001 sig
SECONDARY INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - 1,5 AG	5.74; 4.28	<0.001 sig
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	190.47; 209.86; 228.87; 252.90; 206.43; 227.77	<0.001 sig
SECONDARY INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline	563; 631; 95; 35; 51; 51	<0.001 sig
SECONDARY MAINTENANCE: HbA1c at Specified Visits and Endpoint	8.59; 8.69; 6.82; 6.75; 6.49; 6.49	0.204
SECONDARY MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions	190.90; 187.12; 119.50; 127.92; 243.62; 243.55	0.218
SECONDARY MAINTENANCE: Rate of Increase in HbA1c	0.06; 0.05	0.300
SECONDARY MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5%	44.9; 49.1; 40.1; 45.1; 23.7; 26.4	0.134
SECONDARY MAINTENANCE: Incremental Change From Baseline in Body Weight	90.56; 88.62; 2.05; 3.68; 2.71; 4.56	<0.001 sig
SECONDARY MAINTENANCE: Body Weight	90.56; 88.62; 92.64; 92.35; 93.13; 93.24	0.128
SECONDARY MAINTENANCE: Insulin Dose	0.36; 0.43; 0.36; 0.44; 0.37; 0.44	<0.001 sig
SECONDARY MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes	45.3; 49.9; 94.0; 97.9; 30.4; 28.9	0.370
SECONDARY MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes	16.41; 18.56; 21.80; 26.08; 7.70; 5.86	0.497
SECONDARY MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol	5.66; 5.87; 10.48; 11.71; 4.82; 5.84	0.004 sig
SECONDARY MAINTENANCE: Change From Baseline to Endpoint in HbA1c	8.59; 8.69; -1.38; -1.59; 0.71; 0.61	0.204
SECONDARY MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes	8.44; 9.70	0.036 sig
SECONDARY MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes	9.42; 9.87	0.708
SECONDARY MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group	96; 152; 45; 94; 6; 26	0.028 sig
SECONDARY MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group	112; 148; 78; 97; 12; 26	0.738
SECONDARY MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c	8.27; 8.77	<0.001 sig
SECONDARY MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c	8.54; 8.80	0.043 sig
SECONDARY MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group	97; 121; 46; 149	<0.001 sig
SECONDARY MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group	110; 121; 88; 147	0.032 sig
SECONDARY MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline	16; 13; 73; 175; 22; 22	0.037 sig
SECONDARY MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline	14; 5; 115; 185; 25; 21	0.006 sig
SECONDARY MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG	6.29; 5.39	0.004 sig
SECONDARY MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG	5.93; 5.73	0.553
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	219.28; 233.51; 200.60; 210.44	0.010 sig
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	223.98; 231.66; 201.42; 207.96	0.516
SECONDARY ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint	8.01; 8.03; 8.00; 7.98; 0.19; 0.04	0.770
SECONDARY ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5%	12.5; 16.0; 22.0; 18.2; 8.8; 13.9	0.027 sig
SECONDARY ADDENDUM: 7-point SMPG Profiles	145.33; 151.15; 126.22; 139.45; 168.71; 170.36	0.241
SECONDARY ADDENDUM: Incremental Change From Baseline in Body Weight	91.85; 93.63; 89.25; 90.09; 0.38; 0.28	0.745
SECONDARY ADDENDUM: Body Weight	91.85; 93.63; 89.25; 90.09; 91.53; 93.71	0.467
SECONDARY ADDENDUM: Insulin Dose	0.55; 0.55; 0.46; 0.46; 0.58; 0.57	0.837
SECONDARY ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes	40.9; 41.5; 34.9; 40.9; 53.7; 56.1	0.953
SECONDARY ADDENDUM: Rate of Self-reported Hypoglycemic Episodes	11.10; 10.11; 12.11; 11.18; 11.54; 10.73	0.623
SECONDARY ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24	7.84; 7.77; 7.31; 7.37; 8.18; 7.73	0.917
SECONDARY ADDENDUM: HbA1c at Specified Visits and Endpoint	8.01; 8.03; 8.00; 7.98; 8.11; 8.07	0.770

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT00279201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.