| CTRI Number |
CTRI/2008/091/000276 [Registered on: 12/12/2008] |
| Last Modified On: |
19/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study the blood sugar lowering effects and safety of oral insulin in patients with type 2 Diabetes Mellitus. |
Scientific Title of Study
Modification(s)
|
A Multicenter, Randomized, Double-Blind, Placebo Control Study of IN-105 tablets [oral insulin] in Patients with Type 2 Diabetes Mellitus who have inadequate Glycemic Control on Optimal doses of Extended Release Metformin Tablets. |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Registry |
| IN105-CT3-004-08 (1.01; 16 Feb 2009) |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Prasanna Kumar |
| Address |
New BEL Road,
MSRIT post Bangalore Karnataka
Bangalore
KARNATAKA
560054
India |
| Phone |
08022183009 |
| Fax |
08022183012 |
| Email |
kmprasanna@vsnl.com |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sarika S Deodhar |
| Address |
Biocon Research Limited – SEZ Unit,Plot No 2 and 3, Phase IV BIA,Bommasandra-Jigani Link Road,
Bangalore, India
Bangalore
KARNATAKA
560 099
India |
| Phone |
08028085318 |
| Fax |
08028085000 |
| Email |
Sarika.Deodhar@biocon.com |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Dr Sarika S Deodhar |
| Address |
Biocon Research Limited – SEZ Unit,Plot No 2 and 3, Phase IV-BIA,Bommasandra-Jigani Link Road,
Bangalore, India
Bangalore
KARNATAKA
560 099
India |
| Phone |
08028085318 |
| Fax |
08028085000 |
| Email |
Sarika.deodhar@biocon.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Biocon Limited |
| Address |
20th KM Hosur Road Electronics City Bangalore 560100 |
| Type of Sponsor |
Other [Biotech/Pharma Industry] |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 16 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Sailesh Lodha |
Fortis Escorts Hospital |
,-302017
Jaipur
|
0141-2547000
0141-2547002
saileshlodha@rediffmail.com |
| Dr. Premalatha Varthakavi |
BYL Nair Ch. Hospital |
Dept. of Endocrinology,Dr. A L Nair Road-400008
Mumbai
|
022-23081490-extn:163 or 182
022-23080601
premavar@hotmail.com |
| Dr.Padmalatha Devi.M |
DiabetOmics India. |
6-3-349/17B,-500 034
Hyderabad
|
9885411110
040- 66661331
drpadmalatha@gmail.com |
| Dr. S.R. Aravind |
Diacon Hospital |
Diabetes Care and Research Centre ,359-360, 19th Main, Ist Block-560010
Bangalore
|
802310553
080-23130553
draravind@hotmail.com |
| Dr. V.Seshiah |
Dr V Seshiah Diabetes Care and Research Institute |
31/A, Ormes Road,Kilpauk-600010
Chennai
|
044-26412296, 26615757
vseshiah@gmail.com |
| Dr Pramod Gandhi |
Gandhi Research Institute |
C-1, Shreevarhan Complex,Wardha Road, Ramdaspeth-695011
Nagpur
|
04712554911
04712554913
drpdgandhi1@yahoo.co.in |
| Dr. Mathew John |
Health and Research Center |
T.C. 1/907, First Floor, Devi Scans Building, ,Kumarapuram, Medical College Post, -695011
Not Applicable
|
04712554911
04712554913
drmathewjohn@yahoo.com |
| Dr.S.S.Srikanta |
JNANA SANJEEVINI MEDICAL CENTER |
#2,1A cross, Marenahalli,,JP nagar 2nd phase -560078
Bangalore
|
08026493040
08026493050
jsmcindia@gmail.com |
| Dr. Basavangowdappa |
JSS Medical College Hospital |
Ramanuja Road, Agrahara,-570 004
Mysore
|
0821 - 2548368
0821- 2548368
hbgowda@gmail.com |
| Dr.C Yajnik |
KEM Hospital |
Sardar Moodliar Road,Rastapeth-411 011
Pune
|
020-66405731
020- 26111958
diabetestrials@yahoo.com |
| Dr. K.M. Prasanna Kumar |
M.S. Ramaiah Memorial Hospital |
New BEL Road, MSRIT Post,,-560 054
Bangalore
|
080 - 22183009
080 - 22183012
kmprasanna@vsnl.com |
| Dr.V.Mohan |
Madras Diabetes Research Foundation |
No:4, Conran Smith Road,,Gopalapuram-600086
Chennai
|
044 - 43968888
4428350935
drmohans@vsnl.net |
| Dr. Sanjiv Shah |
Mediheights Healthcare Pvt Ltd |
Sailee HT Commercial Complex, Hindustan Naka, Opp Ajanta Pharma, Kandivali(W),-400 067
Mumbai
|
022- 28675113
022- 28680263
sanjiv_d3@rediffmail.com |
| Dr.Anil Bhansali |
Postgraduate Institute of Medical Education & Research |
Sector - 12,-160012
Chandigarh
|
(0)9316977995
anilbhansali_enocrin@rediffmail.com |
| Dr.Krishan G Seshadri |
Shri Ramachandra Medical College & Research Institute |
Porur,-600116
Chennai
|
9940068170
044 24765631
krishnagseshadri@gmail.com |
| Dr.Ganapathi Bantwal |
St.John's medical College and Hospital |
Sarjapur Road,-560 034
Bangalore
|
080 - 22065649 / 22065711
080 - 25635313
mallyaganapathi@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 16 |
| Name of Committee |
Approval Status |
| Central Indiamedicalresearch Ethics Committee. Dr Pramod Gandhi is the PI and the EC is located in nagpur |
Approved |
| Clinicom Ethics Committee located in bnaglore. Dr Padmalatha Devi is the PI |
Approved |
| Diacon Hospital Ethics Committee functions from bangalore and Dr S R Aravind is the PI |
Approved |
| Ethics review board functions form Bnaglore. dr Prasanna Kumar is the PI. |
Approved |
| Independent Human Ethics Committee functions from Trivandrum and Dr Mathew John is the PI |
Approved |
| Institute Ethics Committee functions from Chandigarh. Dr Anil Bhansali is the PI. |
Approved |
| Institutional Ethical Committee functions from Mysore. Dr BasvanGowdappa is the PI |
Approved |
| Institutional Ethical review Board, St.Johns medical College and Hospitalfunctions from Bangalore. Dr Bantwal is the PI |
Approved |
| Institutional Ethics Committee BYL Nair functions form Mumbai. Dr Premalatha is the PI |
Approved |
| Institutional Ethics Committee Fortis Escorts Hospital functions from jaipur . Dr Shailesh Lodha is the PI |
Approved |
| Institutional Ethics Committee functions form Chennai and Dr Krishna Seshadhri is the PI. |
Approved |
| Institutional Ethics Committee located in Chennai.Dr Seshaiah is the PI |
Approved |
| Institutional Ethics Committee of Madras Diabetes Research Foundation functions from Chennai. Dr Mohan is the PI. |
Approved |
| Institutional Ethics Committee, Mediheights Healthcare Pvt Ltd functions fromMumbai. DrSanjiv Shah is the PI |
Approved |
| Jnana Sanjeevini Medical Centerfunctions from Bangalore. Dr Srikanta is the PI |
Approved |
| KEM Hospital Research Centre Ethics Committee functions form Pune. Dr C S Yajnik is the PI |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes mellitus |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
IN-105 |
4 Doses. Participation in the study was upto a maximum of 29 weeks |
| Comparator Agent |
Placebo |
4 Doses. Participation in the study was upto a maximum of 29 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex with established diagnosis of type 2 diabetes mellitus as per revised WHO criteria for at least 24 weeks.
Age - 30 to 65 years.
Fasting Plasma C-peptide >0.6 ng/ml at screening.
Body Mass Index (BMI) 18 to 29.9 kg/m2.
Willingness to provide written informed consent to participate in the study.
Glycosylated haemoglobin (HbA1c) concentrations of >7.5% and & ≤ 10%.
Currently on stable dose of Metformin Extended-Release Tablets at doses ranging between 1 to 2 gm per day for at least 12 weeks prior to the screening visit.
Willingness to fulfil the study requirements for the entire duration of the study.
|
|
| ExclusionCriteria |
| Details |
History of hypersensitivity to the study drugs or to drugs with a similar chemical structure.
History of severe or multiple allergies.
Patients currently on other oral hypoglycemic agents other than extended release metformin or any alternative forms of medications known to affect the glycemic parameters.
Type 1 diabetes mellitus.
Fasting venous plasma glucose >200 mg/dl on two consecutive occasions at screening.
Two or more severe hypoglycaemic episodes requiring hospitalization or intravenous glucose or treatment with glucagon in the past 6 months.
Any hospitalization or emergency room visit due to poor diabetic control within the past 6 months.
Complications of diabetes mellitus including a history or finding of moderate to severe Non Proliferative Diabetic Retinopathy or Proliferative Diabetic retinopathy of any severity, proteinuria >2+ by urine dipstick, serum creatinine of >1.8 mg/dl for males or >1.5 mg/dl for females, history of renal transplant, severe peripheral vascular disease which has resulted in amputation, chronic foot ulcer, claudication or absent pulses, history of autonomic neuropathy.
Current significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the Investigator except patients diagnosed with essential hypertension and/or hyperlipidemia if well controlled on stable doses of antihypertensive and/or hypolipidemic drugs for at least 3 months prior to the screening visit.
Impaired hepatic function as shown by an increased Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal range and/or Bilirubin greater than 1.5 times the upper limit of normal range at study entry.
History of cancer in the last 5 years.
Any condition which requires administration of systemic corticosteroid in the last 2 weeks prior to screening or any condition which requires chronic treatment with systemic corticosteroids.
Pregnancy, lactation, or planned pregnancy during the study duration. Women of childbearing potential (any women who is not surgically sterile or > 2 years post menopause) must give consent for using a reliable method of contraception (e.g. double-barrier, tubal ligation or stable hormonal contraception) throughout the study period. Women who become pregnant during the study must be discontinued from the study, but followed for pregnancy outcome.
Blood donation within the last 30 days.
Treatment by another investigational agent during the 3 months prior to inclusion in the trial.
Current or past treatment with insulin or insulin analogues to control diabetes.
Hepatitis B, hepatitis C and/or HIV positive patients.
Current drug or alcohol abuse, or a history which in the opinion of the Investigator will impair patient safety or protocol compliance.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Change in HbA1c from baseline to week 24. |
from randomization (V3) to week 24. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1.Change in HbAIC from
baseline to week 14 |
See under Outcome |
| 10.Investigators Global assessment of tolerability |
NA |
| 4. Change in serum lipids,Body weight, BMI and waist circumference from baselineto weeks 14 and week 24. |
week 14 and week 24 |
| 5. Change in homeostasis model assessment beta cell (Homa-B) and Insulin resistance (HOMA IR) from baseline to weeks 14 and week 24 |
Week 14 and week 24 |
| 6. Change in C -peptide from baseline to weeks 14 and week 24. |
Week 14 and Week 24 |
| 7. Adverse events (including clinically significant laboratory abnormalities) |
NA |
| 8. Immunogenecity by anti-insulin antibody titre at week 8 14 and week 24. |
Week 8, 14 and 24 |
| Change in average SMBG,FPG and 1- and 2-hour standardized test meal PPG valuefrom baseline to weeks 14 and weeks 24 |
week 14 and week 24 |
| Fundoscopic changes |
NA |
| Proprotion of patients achievingHbAIC lesser than or equalto 7% and lesser than or equal to 6.5% at the end of week 14 and 24. |
week14 and week 24 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="264"
Sample Size from India="264" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
13/04/2009 |
| Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
Modification(s)
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
IN105 was noted to have immediate benefits in glucose level control in T2DM patients. however this was not translating to HbAIC improvement. Selective benefit of 10mg possibly due to translation of short term glucose control to HbAIC improvemnt in patients with well controlledfasting sugar levels are noted. mimcking natural insulin delivery is a benefit since it can translate in patients to negligible systemic effectand insulin sparing effect. There was no hypoglycemia, immunogenecity or other AE concerns other than the expectations from any other approved insulin formulations. |
Brief Summary
Modification(s)
|
The study was planned to assess the safety and efficacy of post prandial oral insulin on diabetes control in patients with T2DM. significant difference in mean1 hour post standard test meal postprandialglucose at 14 and 24 weeks was noted. C-peptide levels at 1 hour and at 2 hours after standard test meal sghowed significant differences. The study did not show difference in HbAIC. there were no safety concerns. |
