| CTRI Number |
CTRI/2009/091/000123 [Registered on: 16/04/2009] |
| Last Modified On: |
12/09/2012 |
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy and Safety Study of Alogliptin Compared to Glipizide in Elderly Diabetics |
|
Scientific Title of Study
|
A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Subjects with Type 2 Diabetes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT00707993 |
ClinicalTrials.gov |
| SYR-322_303 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
Not Applicable
N/A
India |
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubhangi Desai |
| Designation |
|
| Affiliation |
SIRO Clinpharm Pvt. Ltd. |
| Address |
SIRO Clinpharm Pvt. Ltd.
DIL Complex, II Floor, S.V. Road, Nr. Tatwagyan Vidyapeeth, Ghodbunder Road
Thane
MAHARASHTRA
400 607
India |
| Phone |
022-2584 8000 |
| Fax |
022- 2584 8275 |
| Email |
shubhangi.desai@siroclinpharm.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Rajendra Talele |
| Designation |
|
| Affiliation |
|
| Address |
SIRO Clinpharm Pvt. Ltd.
DIL Complex, II Floor, S.V. Road, Nr. Tatwagyan Vidyapeeth, Ghodbunder Road
Thane
MAHARASHTRA
400 607
India |
| Phone |
022-2584 8000 |
| Fax |
022- 2584 8275 |
| Email |
rajendra.talele@siroclinpharm.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Takeda Global Research & Development Centre (Europe) Ltd (TGRD)
61 Aldwych
London WC2B 4AE
United Kingdom
|
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neeta Deshpande |
Belgaum Diabetes Centre |
,-
Belgaum
KARNATAKA |
neetarohit@gmail.com |
| Dr Mala Dharmalingam |
Bhagwan Mahavir Jain Hospital |
,-560052
Bangalore
KARNATAKA |
jain.endo@gmail.com |
| Dr Sanjay Kalra |
Bharti Research Institute of Diabetes and Endocrinology |
,-132001
Karnal
HARYANA |
brideknl@gmail.com |
| Dr Manish Shirsat |
IRL Research Centre |
,-400099
Mumbai
MAHARASHTRA |
rcama@irlresearch.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Bhagwan Mahaveer Jain Hospital, Bangalore |
Approved |
| Bharti Research Institute of Diabetes and Endocrinology (BRIDE), Institutional Ethics committee |
Approved |
| CLINICOM, Bangalore for Belgaum site |
Approved |
| CLINICOM, Bangalore for Mumbai site |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Diabetes Type II, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Glipizide |
SYR-322 placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks |
| Intervention |
SYR-322 |
SYR-322 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1.Has a diagnosis of type 2 diabetes mellitus with either:
a.Failed diet and exercise therapy alone as demonstrated by inadequate glycemic control while receiving no antidiabetic treatment within the two months prior to Screening, or
b.Failed treatment with oral monotherapy alone (may include treatment with two or more antidiabetic agents if for less than 7 days) as demonstrated by inadequate glycemic control within the two months prior to Screening.
2.Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2.
3.If regularly using other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening.
4.Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
5.Able and willing to monitor their own blood glucose concentrations with a home glucose monitor.
6.No major illness or debility that in the investigator's opinion prohibits the participant from completing the study.
|
|
| ExclusionCriteria |
| Details |
1.Systolic blood pressure greater than or equal to 160 mm Hg and/or diastolic pressure greater than or equal to 100 mm Hg.
2.Hemoglobin less than or equal to 12 g/dL (less than or equal to 120 gm/L) for males or less than or equal to 10 g/dL (less than or equal to 100 gm/L) for females.
3.Alanine aminotransferase greater than or equal to 3 times the upper limit of normal.
4.Calculated creatinine clearance less than or equal to 50 mL/min.
5.Thyroid-stimulating hormone level outside of the normal range.
6.History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening.
7.History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
8.History of treated diabetic gastroparesis, gastric banding, or gastric bypass surgery.
9.New York Heart Association Class III or IV heart failure regardless of therapy.
10.History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening.
11.History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
12.History of infection with Human Immunodeficiency Virus.
13.History of a psychiatric disorder that will affect the subject's ability to participate in the study.
14.History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.
15.History of alcohol or substance abuse within the 2 years prior to Screening.
16.History of treatment with any weight-loss drugs or oral or systemically injected glucocorticoids within the 3 months prior to Screening.
17.Receipt of any investigational drug within the 30 days prior to Screening.
18.Prior treatment in an investigational study of alogliptin.
19.Clinically significant medical abnormality or disease or clinically significant abnormal findings at Screening (other than type 2 diabetes) that, in the opinion of the investigator, should exclude the subject from the study.
20.Has donated more than 400 mL of blood within the 90 days preceding their participation in the study.
21.Has hypersensitivity or has had an anaphylactic reaction(s) to any DPP-4 inhibitor drug.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from baseline in Glycosylated Hemoglobin |
Week 52 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Glycosylated Hemoglobin |
Weeks 4, 8, 12, 16, 20, 26, 34, and 42. |
| Incidence of hypoglycemia |
At Each Occurrence |
| Incidence of marked hyperglycemia (FPG ≥200 mg/dL) |
At Each Occurrence |
| Fasting Plasma Glucose |
Weeks 2, 4, 8, 12, 16, 20, 26, 34, 42, and 52 |
| 2-hr postprandial glucose |
Weeks 26 and 52 |
| Proinsulin |
Weeks 12, 26, 42, and 52 |
| Insulin |
Weeks 12, 26, 42, and 52 |
| Proinsulin/Insulin ratio |
Weeks 12, 26, 42, and 52 |
| Homeostasis model assessment-B-cell function |
Weeks 12, 26, 42, and 52 |
| Body weight |
Weeks 8, 12, 26, 42, and 52 |
| Serum lipids |
Week 8, 12, 26, 42, and 52 |
| High sensitivity C-reactive protein testing |
Weeks 12, 26, 42, and 52 |
| Clinical response endpoint incidence of glycosylated hemoglobin measurement less than or equal to 6.5%. |
Week 52 |
| Clinical response endpoint incidence of glycosylated hemoglobin decrease from baseline greater than or equal to 1.0%. |
Week 52 |
| Clinical response endpoint incidence of glycosylated hemoglobin decrease from baseline greater than or equal to 1.0%. |
Week 52 |
| Clinical response endpoint incidence of glycosylated hemoglobin decrease from baseline greater than or equal to 2.0%. |
Week 52 |
| Quality of Life scale scores and Patient Reported Outcome measures |
Week 52 |
| Incidence of hyperglycemic rescue. |
At Each Occurrence |
| Clinical response endpoint incidence of glycosylated hemoglobin measurement less than or equal to 7.0%. |
Week 52 |
| Clinical response endpoint incidence of glycosylated hemoglobin decrease from baseline greater than or equal to 0.5%. |
Week 52 |
|
|
Target Sample Size
|
Total Sample Size="0"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
30/06/2008 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years=""
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Type 2 diabetes is among the most common chronic condition in adults 65 years of age or older. A recent National Health and Nutrition Examination Survey reported that more than 20% of adults aged 65 years or older have diabetes. These individuals are often under-treated with respect to glucose-lowering medications, and their care is complicated by the extent of their clinical and functional status. Age-related changes in physiology, diabetes-associated illnesses and other illnesses (such as renal, cardiac, and hepatic insufficiency), as well as use of multiple medications make standard oral anti-hyperglycemic therapy and insulin use problematic. In addition, hypoglycemia is more common and severe in older rather than younger patients taking oral antidiabetic drugs which can precipitate serious events such as falls and hip fractures. While avoidance of hypoglycemia is paramount in elderly diabetic patients, many commonly used medications are associated with a substantial risk for hypoglycemia. New classes of drug which avoid such complications in the elderly population are of increasing interest as this population continues to expand. Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. SYR-322 is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes. This study will compare the effectiveness and safety of SYR-322 with that of glipizide (a commonly used diabetes medication) in adults who are 65 to 90 years of age with Type 2 diabetes. Individuals who participate in this study will either have failed diet and exercise therapy alone during the 2 months before Screening, or will have been receiving a single oral antidiabetic medication without obtaining good blood glucose (sugar) control. Each participant will be required to commit to screening visits. Study participation is anticipated to be up to 59 weeks. The total target number to be randomized in India would be 40. The total target number randomized in India is 35. < |