AzTrials
AzTrials

Diabetes Mellitus Type 2Phase 3NCT01051011

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

A Phase 3 study testing insulin glargine, metformin and taspoglutide in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 56 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus Type 2
What is being tested?
insulin glargine, metformin and taspoglutide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
370 participants
Where
56 sitesin 7 countries
Study dates
Jan 2010to Dec 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

56 sites in 7 countries.

56 sites in 7 countries

China16 sites

  • Study site

    Beijing, 10029

  • Study site

    Beijing, 100730

  • Study site

    Beijing, 100853

  • Study site

    Beijng, 100700

  • Study site

    Chengdu, 610041

  • Study site

    Chongqing, 400010

  • Study site

    Guangzhou, 510120

  • Study site

    Hangzhou, 310003

  • Study site

    Hefei, 230022

  • Study site

    Nanjing, 210006

  • Study site

    Nanjing, 210036

  • Study site

    Nanning, 530021

  • Study site

    Shanghai, 200080

  • Study site

    Shijiazhuang, 050051

  • Study site

    Tianjin, 201203

  • Study site

    Tianjin (天津), 300052

Other trials in China

South Korea16 sites

  • Study site

    Busan, 614-735

  • Study site

    Daegu, 42472

  • Study site

    Daegu, 705-717

  • Study site

    Gyeonggi-do, 410-773

  • Study site

    Gyeonggi-do, 443-380

  • Study site

    Gyeonggi-do, 463-712

  • Study site

    Incheon, 405-760

  • Study site

    Kangwon-do, 220-701

  • Study site

    Kyounggi-do, 420-717

  • Study site

    Seoul, 0

  • Study site

    Seoul, 110-746

  • Study site

    Seoul, 130-702

  • Study site

    Seoul, 134-701

  • Study site

    Seoul, 135-720

  • Study site

    Seoul, 137-701

  • Study site

    Seoul, 139-872

Other trials in South Korea

Malaysia7 sites

  • Study site

    George Town, 10450

  • Study site

    Johor Bahru, 80200

  • Study site

    Kelantan, 16150

  • Study site

    Kuala Lumpur, 50586

  • Study site

    Kuala Lumpur, 50603

  • Study site

    Kuala Selangor

  • Study site

    Putrajaya, 62250

Other trials in Malaysia

Philippines6 sites

  • Study site

    Cebu, 6000

  • Study site

    Iloilo City, 5000

  • Study site

    Manila, 1000

  • Study site

    Manila, 1357

  • Study site

    Manila, 1503

  • Study site

    Pasig, 1605

Other trials in Philippines

Taiwan6 sites

  • Study site

    Chia-Yi City, 60002

  • Study site

    Taichung, 404

  • Study site

    Tainan, 710

  • Study site

    Taipei, 00112

  • Study site

    Taipei, 220

  • Study site

    Taoyuan County, 333

Other trials in Taiwan

Thailand4 sites

  • Study site

    Bangkok, 10330

  • Study site

    Bangkok, 10400

  • Study site

    Chiang Mai, 50200

  • Study site

    Nakhonratchasima, 30000

Other trials in Thailand

Hong Kong1 site

  • Study site

    Hong Kong

Other trials in Hong Kong

About this study

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.

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.

Being tested
insulin glargine, metformin, taspoglutide
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • insulin glargineDrug

    initial dose 10 international units (IU) sc daily, titrated according to the mean FPG, 24 (-52) weeks

  • metforminDrug

    as prescribed

  • taspoglutideDrug

    10mg sc weekly, 24 (-52) weeks

  • taspoglutideDrug

    10mg sc weekly the 1st 4 weeks followed by 20mg sc weekly, 24 (-52) weeks

Study groups in NCT01051011
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: metformin; Drug: taspoglutide
2ExperimentalNot described
Receives: Drug: metformin; Drug: taspoglutide
3Active comparatorNot described
Receives: Drug: insulin glargine; Drug: metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycemic control assessed by HbA1c

    Measured: week 24

Secondary outcomes (4)

  1. Fasting plasma glucose, incidence of hypoglycemia, proportion of patients achieving target HbA1c

    Measured: week 24

  2. Body weight, lipid profile (triglycerides, total cholesterol, LDL and HDL cholesterol, LDL/HDL ratio)

    Measured: week 24

  3. Safety and tolerability: Adverse events (including hypoglycemia), vital signs, laboratory parameters

    Measured: throughout study, laboratory assessments weeks 12, 24, 32 and 52

  4. Meal tolerance test (in a subset of patients): Glucose, insulin, C-peptide, glucagon values

    Measured: week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2010
  4. Study completionDec 2010

Why it stopped: high discontinuation rates mainly due to GI tolerability and implementation of risk mitigation plan to address hypersensitivity reactions

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
370 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01051011
Sponsor's protocol ID
ZC22565
Status last verified
Nov 2016
First submitted
15 Jan 2010
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin glargine, metformin and taspoglutide in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 56 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in China, South Korea, Malaysia, Philippines, Taiwan and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: high discontinuation rates mainly due to GI tolerability and implementation of risk mitigation plan to address hypersensitivity reactions). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycemic control assessed by HbA1c (time frame: week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01051011.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in