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A Study to Compare Taspoglutide and Insulin Glargine in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Sulfonylurea Combination Therapy

Primary Purpose

Diabetes Mellitus Type 2

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
insulin glargine
metformin
taspoglutide
taspoglutide
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult patients, 18-75 years of age
  • type 2 diabetes mellitus, treated with stable dose of metformin and sulfonylurea for >/= 12 weeks prior to screening
  • HbA1c 7-10% at screening
  • body weight stable (+/-5%) for >/= 12 weeks prior to screening
  • fasting C-peptide >/=1ng/ml
  • treatment-naïve for insulin

Exclusion Criteria:

  • diagnosis or history of type 1 diabetes mellitus or secondary forms of diabetes
  • acute metabolic diabetic complications or evidence of clinically significant diabetic complications
  • clinically symptomatic gastrointestinal disease
  • history of chronic pancreatitis or acute idiopathic pancreatitis
  • >3 episodes of severe hypoglycemia within 6 months prior to screening
  • miocardial infarcion, unstable angina pectoris, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within 6 months prior to screening
  • any treatment with exenatide, exendin analogues, GLP-1 or its analogues

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

Glycemic control assessed by HbA1c

Secondary Outcome Measures

Fasting plasma glucose, incidence of hypoglycemia, proportion of patients achieving target HbA1c
Body weight, lipid profile (triglycerides, total cholesterol, LDL and HDL cholesterol, LDL/HDL ratio)
Safety and tolerability: Adverse events (including hypoglycemia), vital signs, laboratory parameters
Meal tolerance test (in a subset of patients): Glucose, insulin, C-peptide, glucagon values

Full Information

First Posted
January 15, 2010
Last Updated
November 1, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01051011
Brief Title
A Study to Compare Taspoglutide and Insulin Glargine in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Sulfonylurea Combination Therapy
Official Title
A Multi-center, Randomized, Open-label, Active-controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin-naive Type 2 Diabetic Patients Inadequately Controlled With Metformin and Sulphonylurea Combination Therapy.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
high discontinuation rates mainly due to GI tolerability and implementation of risk mitigation plan to address hypersensitivity reactions
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
This randomized, open-label, parallel arm study will compare the safety, tolerability and effect on glycemic control of taspoglutide versus insulin glargine in insulin-naïve patients with type 2 diabetes mellitus inadequately controlled on merformin and sulfonylurea combination therapy. Patients will be randomized to receive either taspoglutide 10mg subcutaneously (sc) weekly, or taspoglutide 10mg sc weekly for 4 weeks followed by 20mg sc weekly, or insulin glargine at an initial dose of 10 international units sc daily. Metformin treatment will be continued in all patients throughout the study, whereas sulfonylurea will be discontinued before starting study treatment. Anticipated time on study treatment is 24 weeks, with an option to continue the assigned treatment for another 28 weeks. Target sample size is 500-600 patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
370 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Description
initial dose 10 international units (IU) sc daily, titrated according to the mean FPG, 24 (-52) weeks
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
as prescribed
Intervention Type
Drug
Intervention Name(s)
taspoglutide
Intervention Description
10mg sc weekly, 24 (-52) weeks
Intervention Type
Drug
Intervention Name(s)
taspoglutide
Intervention Description
10mg sc weekly the 1st 4 weeks followed by 20mg sc weekly, 24 (-52) weeks
Primary Outcome Measure Information:
Title
Glycemic control assessed by HbA1c
Time Frame
week 24
Secondary Outcome Measure Information:
Title
Fasting plasma glucose, incidence of hypoglycemia, proportion of patients achieving target HbA1c
Time Frame
week 24
Title
Body weight, lipid profile (triglycerides, total cholesterol, LDL and HDL cholesterol, LDL/HDL ratio)
Time Frame
week 24
Title
Safety and tolerability: Adverse events (including hypoglycemia), vital signs, laboratory parameters
Time Frame
throughout study, laboratory assessments weeks 12, 24, 32 and 52
Title
Meal tolerance test (in a subset of patients): Glucose, insulin, C-peptide, glucagon values
Time Frame
week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients, 18-75 years of age type 2 diabetes mellitus, treated with stable dose of metformin and sulfonylurea for >/= 12 weeks prior to screening HbA1c 7-10% at screening body weight stable (+/-5%) for >/= 12 weeks prior to screening fasting C-peptide >/=1ng/ml treatment-naïve for insulin Exclusion Criteria: diagnosis or history of type 1 diabetes mellitus or secondary forms of diabetes acute metabolic diabetic complications or evidence of clinically significant diabetic complications clinically symptomatic gastrointestinal disease history of chronic pancreatitis or acute idiopathic pancreatitis >3 episodes of severe hypoglycemia within 6 months prior to screening miocardial infarcion, unstable angina pectoris, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within 6 months prior to screening any treatment with exenatide, exendin analogues, GLP-1 or its analogues
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Beijing
ZIP/Postal Code
10029
Country
China
City
Beijing
ZIP/Postal Code
100730
Country
China
City
Beijing
ZIP/Postal Code
100853
Country
China
City
Beijng
ZIP/Postal Code
100700
Country
China
City
Chengdu
ZIP/Postal Code
610041
Country
China
City
Chongqing
ZIP/Postal Code
400010
Country
China
City
Guangzhou
ZIP/Postal Code
510120
Country
China
City
Hangzhou
ZIP/Postal Code
310003
Country
China
City
Hefei
ZIP/Postal Code
230022
Country
China
City
Nanjing
ZIP/Postal Code
210006
Country
China
City
Nanjing
ZIP/Postal Code
210036
Country
China
City
Nanning
ZIP/Postal Code
530021
Country
China
City
Shanghai
ZIP/Postal Code
200080
Country
China
City
Shi Jiazhuang
ZIP/Postal Code
050051
Country
China
City
Tianjin (天津)
ZIP/Postal Code
300052
Country
China
City
Tianjin
ZIP/Postal Code
201203
Country
China
City
Hong Kong
Country
Hong Kong
City
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of
City
Daegu
ZIP/Postal Code
42472
Country
Korea, Republic of
City
Daegu
ZIP/Postal Code
705-717
Country
Korea, Republic of
City
Gyeonggi-do
ZIP/Postal Code
410-773
Country
Korea, Republic of
City
Gyeonggi-do
ZIP/Postal Code
443-380
Country
Korea, Republic of
City
Gyeonggi-do
ZIP/Postal Code
463-712
Country
Korea, Republic of
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
City
Kangwon-do
ZIP/Postal Code
220-701
Country
Korea, Republic of
City
Kyounggi-do
ZIP/Postal Code
420-717
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
0
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
110-746
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
134-701
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
139-872
Country
Korea, Republic of
City
Johor Bahru
ZIP/Postal Code
80200
Country
Malaysia
City
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
City
Penang
ZIP/Postal Code
10450
Country
Malaysia
City
Putrajaya
ZIP/Postal Code
62250
Country
Malaysia
City
Selangor
Country
Malaysia
City
Cebu
ZIP/Postal Code
6000
Country
Philippines
City
Iloilo
ZIP/Postal Code
5000
Country
Philippines
City
Manila
ZIP/Postal Code
1000
Country
Philippines
City
Manila
ZIP/Postal Code
1357
Country
Philippines
City
Manila
ZIP/Postal Code
1503
Country
Philippines
City
Pasig
ZIP/Postal Code
1605
Country
Philippines
City
Chia-Yi City
ZIP/Postal Code
60002
Country
Taiwan
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
City
Taipei
ZIP/Postal Code
00112
Country
Taiwan
City
Taipei
ZIP/Postal Code
220
Country
Taiwan
City
Taoyuan County
ZIP/Postal Code
333
Country
Taiwan
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
City
Nakhonratchasima
ZIP/Postal Code
30000
Country
Thailand

12. IPD Sharing Statement

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A Study to Compare Taspoglutide and Insulin Glargine in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Sulfonylurea Combination Therapy

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