Clinical Trials List
Protocol NumberYC28037
2013-04-01 - 2015-06-30
Phase III
Terminated3
ICD-10E11.9
Type 2 diabetes mellitus without complications
ICD-10E13.9
Other specified diabetes mellitus without complications
ICD-9250.00
Diabetes mellitus without mention of complication, Type II [non-insulin dependent type][NIDDM type] [ adult-onset type] or unspecified type, not stated as uncontrolled
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF ALEGLITAZAR MONOTHERAPY COMPARED WITH PLACEBO IN PATIENTS WITH TYPE 2 DIABETES MELLITUS (T2D) WHO ARE DRUG-NAÏVE TO ANTI-HYPERGLYCEMIC THERAPY
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Trial Applicant
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Sponsor
F. Hoffmann-La Roche AG
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chung-Ze Wu Division of Endocrinology
- Jiunn-Diann Lin Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Wen-Yuan Lin Division of Family Medicine
- 黃國欽 Division of Endocrinology
- 王子源 Division of Endocrinology
- Chih Hsueh Lin Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
TYPE 2 DIABETES
Objectives
The primary objective for this study is:
To evaluate the efficacy of aleglitazar on glycemic control compared with placebo in
patients with T2D who are drug-naïve to anti-hyperglycemic therapy, as assessed by
HbA1c after 26 weeks of treatment
Secondary Objectives
The secondary objectives for this study are:
• To evaluate the efficacy of aleglitazar compared with placebo in drug naïve patients with
T2D, on the lipid profile, additional parameters of diabetes control, and other markers of
insulin sensitivity and cardiovascular risk
• To assess the safety and tolerability of aleglitazar versus placebo
Test Drug
Aleglitazar (RO0728804)
Active Ingredient
Aleglitazar (RO0728804)
Dosage Form
tablet
Dosage
150
Endpoints
Primary:
• Change from baseline in HbA1c at week 26
Secondary:
• Change from baseline in HDL-C, triglycerides, triglycerides/HDL-C ratio, LDL-C,
apolipoprotein B (Apo B), non HDL-C, apolipoprotein A1 (Apo A1), and total cholesterol at
week 26
• Change from baseline in FPG at week 26
• Responder rates, defined as target HbA1c: < 7.0 %, < 6.5%, at week 26
• Change from baseline in homeostatic indexes of insulin sensitivity (by HOMA-IS) and beta
cell function (by HOMA-BCF) at week 26
• Change from baseline in other markers of insulin sensitivity and cardiovascular risk (hsCRP,
adiponectin, UACR, FFAs) at week 26
• Change from baseline in HbA1c at week 26
Secondary:
• Change from baseline in HDL-C, triglycerides, triglycerides/HDL-C ratio, LDL-C,
apolipoprotein B (Apo B), non HDL-C, apolipoprotein A1 (Apo A1), and total cholesterol at
week 26
• Change from baseline in FPG at week 26
• Responder rates, defined as target HbA1c: < 7.0 %, < 6.5%, at week 26
• Change from baseline in homeostatic indexes of insulin sensitivity (by HOMA-IS) and beta
cell function (by HOMA-BCF) at week 26
• Change from baseline in other markers of insulin sensitivity and cardiovascular risk (hsCRP,
adiponectin, UACR, FFAs) at week 26
Inclution Criteria
1. Men and women aged at least 18 years at screening. Women of child-bearing
potential using highly effective, medically approved birth control methods (eg,
hormonal contraceptives, IUD, barrier contraception) must be willing to use the
same methods of contraception during the whole course of the study
2. Patients diagnosed with T2D within 12 months prior to screening
3. Patients who are drug naïve (defined as no anti-hyperglycemic medication for
at least 12 weeks prior to screening and for not longer than 3 consecutive
months at any time in the past)
4. HbA1c ≥ 7% and ≤ 9.5% at screening or within 4 weeks prior to screening (by
local laboratory) and at pre-randomization visit (by central laboratory)
5. FPG ≤ 13.3 mmol/L (≤ 240 mg/dL) at pre-randomization visit (by central
laboratory)
6. Agreement to maintain diet and exercise habits implemented during the run-in phase during the full course of the study
7. Able and willing to provide written informed consent and to comply with the study protocol
potential using highly effective, medically approved birth control methods (eg,
hormonal contraceptives, IUD, barrier contraception) must be willing to use the
same methods of contraception during the whole course of the study
2. Patients diagnosed with T2D within 12 months prior to screening
3. Patients who are drug naïve (defined as no anti-hyperglycemic medication for
at least 12 weeks prior to screening and for not longer than 3 consecutive
months at any time in the past)
4. HbA1c ≥ 7% and ≤ 9.5% at screening or within 4 weeks prior to screening (by
local laboratory) and at pre-randomization visit (by central laboratory)
5. FPG ≤ 13.3 mmol/L (≤ 240 mg/dL) at pre-randomization visit (by central
laboratory)
6. Agreement to maintain diet and exercise habits implemented during the run-in phase during the full course of the study
7. Able and willing to provide written informed consent and to comply with the study protocol
Exclusion Criteria
1. Women who are pregnant, intending to become pregnant during the study period, currently lactating females, or women of child-bearing potential not using highly effective, medically approved birth control methods
2. Diagnosis or history of:
a. Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes, eg, acromegaly or Cushing’s
syndrome
b. acute metabolic diabetic complications such as ketoacidosis or
hyperosmolar coma within the past 6 months
3. Any previous treatment with a thiazolidinedione or with a dual PPAR agonist
4. Any body weight lowering or lipoprotein-modifying therapy (eg, fibrates) within 12 weeks prior to screening with the exception of stable (≥ 1 month) statin therapy
5. Prior intolerance to a fibrate
6. Treatment with any herbal/over-the-counter preparations that may affect glycemic control within 12 weeks prior to screening
7. Triglycerides (fasting) > 4.5 mmol/L (> 400 mg/dL) at screening or within 4 weeks prior to screening (by local laboratory)
8. Patients with clinically apparent liver disease characterized by either one of the following:
a. ALT or AST > 3x upper limit of normal (ULN) confirmed on two
consecutive measurements (by local laboratory) during the
screening period
b. impaired excretory (eg, hyperbilirubinemia) and/or synthetic function, or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites and bleeding from oesophageal varices.
c. Acute viral or active autoimmune, alcoholic, or other types of
hepatitis
9. Anemia defined as hemoglobin < 6.21 mmol/L (< 10 g/dL; < 100 g/L) or hematocrit < 30% at or within 4 weeks prior to screening (by local laboratory)
10. Estimated GFR using modification of diet in renal disease formula (eGFRMDRD) < 45/mL/min/1.73m2 at screening or within 4 weeks prior to screening (by local laboratory)
11. CPK elevated > 3x ULN at screening or within 4 weeks prior to screening (by local laboratory)
12. Symptomatic congestive heart failure classified as New York Heart Association (NYHA) class II-IV at screening
13. Myocardial infarction, ACS or transient ischemic attack/stroke within 6 months prior to screening visit
14. Known macular edema at screening or prior to screening visit
15. Diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years
16. Uninvestigated hematuria present during the screening period
17. Any concurrent medical condition/disorder that, in the opinion of the
Investigator, is likely:
- to interfere with the patient’s ability to complete the entire study period or to participate in all aspects of the trial
- to require, during the study, the administration of a treatment that would
affect the interpretation of the efficacy and safety data
18. Chronic oral or parenteral corticosteroid treatment (>2 weeks) within 3 months prior to screening
19. Uncontrolled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg)
despite stable (for at least 4 weeks) anti-hypertensive treatment at screening visit
20. Use of investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening unless local health authority guidelines mandate a longer period
21. History of active substance abuse (including alcohol) within the past 2 years
22. Potentially unreliable patients and those judged by the Investigator to be unsuitable for the study
2. Diagnosis or history of:
a. Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes, eg, acromegaly or Cushing’s
syndrome
b. acute metabolic diabetic complications such as ketoacidosis or
hyperosmolar coma within the past 6 months
3. Any previous treatment with a thiazolidinedione or with a dual PPAR agonist
4. Any body weight lowering or lipoprotein-modifying therapy (eg, fibrates) within 12 weeks prior to screening with the exception of stable (≥ 1 month) statin therapy
5. Prior intolerance to a fibrate
6. Treatment with any herbal/over-the-counter preparations that may affect glycemic control within 12 weeks prior to screening
7. Triglycerides (fasting) > 4.5 mmol/L (> 400 mg/dL) at screening or within 4 weeks prior to screening (by local laboratory)
8. Patients with clinically apparent liver disease characterized by either one of the following:
a. ALT or AST > 3x upper limit of normal (ULN) confirmed on two
consecutive measurements (by local laboratory) during the
screening period
b. impaired excretory (eg, hyperbilirubinemia) and/or synthetic function, or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites and bleeding from oesophageal varices.
c. Acute viral or active autoimmune, alcoholic, or other types of
hepatitis
9. Anemia defined as hemoglobin < 6.21 mmol/L (< 10 g/dL; < 100 g/L) or hematocrit < 30% at or within 4 weeks prior to screening (by local laboratory)
10. Estimated GFR using modification of diet in renal disease formula (eGFRMDRD) < 45/mL/min/1.73m2 at screening or within 4 weeks prior to screening (by local laboratory)
11. CPK elevated > 3x ULN at screening or within 4 weeks prior to screening (by local laboratory)
12. Symptomatic congestive heart failure classified as New York Heart Association (NYHA) class II-IV at screening
13. Myocardial infarction, ACS or transient ischemic attack/stroke within 6 months prior to screening visit
14. Known macular edema at screening or prior to screening visit
15. Diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years
16. Uninvestigated hematuria present during the screening period
17. Any concurrent medical condition/disorder that, in the opinion of the
Investigator, is likely:
- to interfere with the patient’s ability to complete the entire study period or to participate in all aspects of the trial
- to require, during the study, the administration of a treatment that would
affect the interpretation of the efficacy and safety data
18. Chronic oral or parenteral corticosteroid treatment (>2 weeks) within 3 months prior to screening
19. Uncontrolled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg)
despite stable (for at least 4 weeks) anti-hypertensive treatment at screening visit
20. Use of investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening unless local health authority guidelines mandate a longer period
21. History of active substance abuse (including alcohol) within the past 2 years
22. Potentially unreliable patients and those judged by the Investigator to be unsuitable for the study
The Estimated Number of Participants
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Taiwan
30 participants
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Global
400 participants
