Diabetes Mellitus, Type 2NCT01147627
Effect of Different Interventions on Glycemic Control and β-cell Function in Newly Diagnosed Type 2 Diabetic Patients
A study testing exenatide injection, Mixed Protamine Zinc Recombinant Human Insulin Lispro 25R and Pioglitazone in people with Diabetes Mellitus, Type 2 and Newly Diagnosed, run by Sun Yat-sen University at 25 sites in China.
Trial summary
The purpose of this study is to investigate and evaluate the effects of different interventions (1. exenatide, 2. insulin, 3. thiazolidinedione) on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Newly Diagnosed
- What is being tested?
- exenatide injection, Mixed Protamine Zinc Recombinant Human Insulin Lispro 25R and Pioglitazone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 25 sitesChina
- Study dates
- Aug 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- newly-diagnosed type 2 diabetic patients, drug naïve
- age 30~70 years
- HbA1c 7.0~10.0%
- BMI 20~35 kg/m2, stable body weight (≤10% variation) for at least 3 months prior to screening
- female patients of reproductive age should practice a reliable method of birth control throughout the study
Who cannot join
- acute or severe chronic diabetic complications
- congestive heart failure (NYHA grade Ⅲ~Ⅳ)
- severe gastrointestinal disease
- severe osteoporosis or history of pathological fracture,or use of bisphosphonates preparation
- other severe intercurrent illness
- serum aminotransferase (ALT and AST) level higher than 2 times of the upper normal limits and/or serum creatinie≥133µmol/L (1.5mg/dL)
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- tested positive for glutamic acid decarboxylase antibody
- use of weight loss drugs, corticosteroids, drugs known to affect gastrointestinal motility, transplantation medications, or any investigational drug
- history of pancreatitis
- serum triglyceride ≥ 5.0 mmol/L
- pregnancy
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
China25 sites
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Beijing Hospital
Beijing, Beijing Municipality, 100730
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Peking University First Hospital
Beijing, Beijing Municipality
The Military General Hospital of Beijing PLA
Beijing, Beijing Municipality
Second Xiangya Hospital of Central-south University
Changsha, Hunan, 410011
The First Affiliated Hospital of Chongqing Medical University
Chongqing
The Second Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
The Affiliated Hospital of Guiyang Medical College
Guiyang, Guizhou
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
The Affiliated Hospital of Inner Mangolia Medical College
Hohhot, Inner Mongolia
The First Affiliated Hospital of Kunming Medical College
Kunming, Yunnan
Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Zhongda Hospital of Southeast University
Nanjing, Jiangsu
The first affiliated hospital of Guangxi Medical College
Nanning, Guangxi, 530000
Qingyuan People's hospital
Qingyuan, Guangdong, 511500
The first Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041
China Medical University
Shenyang, Liaoning, 110001
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
Xijing Hospital of The Fourth Military Medical University
Xi'an, Shaanxi
Affiliated hospital of Guangdong medical college
Zhanjiang, Guangdong, 524001
About this study
Official title: Comparison of Exenatide, Insulin or Pioglitazone on Glycaemic Control and β-cell Function in Drug-naïve Type 2 Diabetic Patients: A Multicentre Randomized Parallel-group Trial
The purpose of this study is to investigate and evaluate the effects of different interventions (1. exenatide, 2. insulin, 3. thiazolidinedione) on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients.
Read the detailed description
One of the fundamental defects in type 2 diabetes mellitus is declining β-cell function. Exenatide targets multiple metabolic disturbances in type 2 diabetes and exerts direct effects on β-cell, which indicates that it may not only contribute to the glucose control but also delay disease progression. There are trials demonstrated efficacy, safety and tolerability of exenatide. However, no study has compared the effects of exenatide with other hypoglycemic therapies with β cell protective function in newly diagnosed and drug-naïve type 2 diabetic patients. This current study is thus designed to evaluate the effects of exenatide, insulin and pioglitazone on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients.
- Conditions
- Diabetes Mellitus, Type 2, Newly Diagnosed
- Being tested
- exenatide injection, Mixed Protamine Zinc Recombinant Human Insulin Lispro 25R, Pioglitazone
- Keywords
- diabetes mellitus, type 2, newly diagnosed, exenatide, premixed insulin analog, thiazolidinedione, β-cell function, glycemic control
- 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.
exenatide injectionDrug
Also called Byetta®(Eli Lilly and Company)
Patients in exenatide group will be treated with exenatide (Byetta®, Eli Lilly and Company) 5 µg BID for the first 4 weeks and then 10 µg BID thereafter.
Mixed Protamine Zinc Recombinant Human Insulin Lispro 25RDrug
Also called Humalog Mix 25®（Eli Lilly and Company)
Patients in insulin group will be treated with premixed insulin analog (Humalog Mix 25, Eli Lilly and Company). The initial insulin doses are 0.4 IU/kg per day(50% before breakfast and 50% before dinner). Insulin doses are titrated following a forced schedule according to blood glucose before breakfast and dinner.
PioglitazoneDrug
Patients in thiazolidinedione group will be treated with Pioglitazone 30mg daily as single dose. The dose will be increased to 45mg daily after 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exenatide | Active comparator | Not described Receives: Drug: exenatide injection |
| Premixed insulin analog | Active comparator | Not described Receives: Drug: Mixed Protamine Zinc Recombinant Human Insulin Lispro 25R |
| pioglitazone | Active comparator | Not described Receives: Drug: Pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks
Measured: 48 weeks
Secondary outcomes (3)
Percentage of Patients Achieving HbA1c <7% and ≤ 6.5% and Effect of Different Interventions on Fasting and Postprandial Plasma Glucose Concentration, Blood Pressure, Lipid Profiles
Measured: 48 weeks
β-cell Function (Acute Insulin Response During IVGTT; HOMA-B, Disposition Index and Proinsulin/Insulin Ratio)
Measured: 48 weeks
Safety and Tolerability in Different Groups
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Amylin Pharmaceuticals, LLC., Ministry of Health, China
- Responsible party
- Principal investigator, Jianping Weng, Sun Yat-sen University
- Investigators
- Jianping Weng, Doctor, Study director, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147627
- Sponsor's protocol ID
- IIT-201007-WJP
- Status last verified
- Jun 2013
- First submitted
- 18 Jun 2010
- Last updated
- 21 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Exenatide, Insulin or Pioglitazone on Glycaemic Control and β-cell Function in Drug-naïve Type 2 Diabetic Patients: A Multicentre Randomized Parallel-group Trial
- ClinicalTrials.gov ID
- NCT01147627
- Acronym / sponsor ID
- IIT-201007-WJP
- Conditions
- Diabetes Mellitus, Type 2, Newly Diagnosed
- Keywords
- diabetes mellitus, type 2, newly diagnosed, exenatide, premixed insulin analog, thiazolidinedione, β-cell function, glycemic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Amylin Pharmaceuticals, LLC., Ministry of Health, China
- Study start
- Aug 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Posted 21 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate and evaluate the effects of different interventions (1. exenatide, 2. insulin, 3. thiazolidinedione) on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients.
Detailed description
One of the fundamental defects in type 2 diabetes mellitus is declining β-cell function. Exenatide targets multiple metabolic disturbances in type 2 diabetes and exerts direct effects on β-cell, which indicates that it may not only contribute to the glucose control but also delay disease progression. There are trials demonstrated efficacy, safety and tolerability of exenatide. However, no study has compared the effects of exenatide with other hypoglycemic therapies with β cell protective function in newly diagnosed and drug-naïve type 2 diabetic patients. This current study is thus designed to evaluate the effects of exenatide, insulin and pioglitazone on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exenatide | Active comparator | Drug: exenatide injection |
| Premixed insulin analog | Active comparator | Drug: Mixed Protamine Zinc Recombinant Human Insulin Lispro 25R |
| pioglitazone | Active comparator | Drug: Pioglitazone |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- newly-diagnosed type 2 diabetic patients, drug naïve
- age 30~70 years
- HbA1c 7.0~10.0%
- BMI 20~35 kg/m2, stable body weight (≤10% variation) for at least 3 months prior to screening
- female patients of reproductive age should practice a reliable method of birth control throughout the study
Key exclusion criteria (11 listed)
- acute or severe chronic diabetic complications
- congestive heart failure (NYHA grade Ⅲ~Ⅳ)
- severe gastrointestinal disease
- severe osteoporosis or history of pathological fracture,or use of bisphosphonates preparation
- other severe intercurrent illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exenatide injectionAlso: Byetta®(Eli Lilly and Company)Patients in exenatide group will be treated with exenatide (Byetta®, Eli Lilly and Company) 5 µg BID for the first 4 weeks and then 10 µg BID thereafter. | Drug | Exenatide |
| Mixed Protamine Zinc Recombinant Human Insulin Lispro 25RAlso: Humalog Mix 25®（Eli Lilly and Company)Patients in insulin group will be treated with premixed insulin analog (Humalog Mix 25, Eli Lilly and Company). The initial insulin doses are 0.4 IU/kg per day(50% before breakfast and 50% before dinner). Insulin doses are titrated following a forced schedule according to blood glucose before breakfast and dinner. | Drug | Premixed insulin analog |
| PioglitazonePatients in thiazolidinedione group will be treated with Pioglitazone 30mg daily as single dose. The dose will be increased to 45mg daily after 4 weeks. | Drug | pioglitazone |
Primary outcome
the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks
Time frame: 48 weeks
3 secondary outcomes
Percentage of Patients Achieving HbA1c <7% and ≤ 6.5% and Effect of Different Interventions on Fasting and Postprandial Plasma Glucose Concentration, Blood Pressure, Lipid Profiles
Time frame: 48 weeks
β-cell Function (Acute Insulin Response During IVGTT; HOMA-B, Disposition Index and Proinsulin/Insulin Ratio)
Time frame: 48 weeks
Safety and Tolerability in Different Groups
Time frame: 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianping Weng, Doctor study director
Third Affiliated Hospital, Sun Yat-Sen University
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exenatide injection, Mixed Protamine Zinc Recombinant Human Insulin Lispro 25R and Pioglitazone in people with Diabetes Mellitus, Type 2 and Newly Diagnosed, run by Sun Yat-sen University at 25 sites in China.
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 5 inclusion and 11 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: finished, as of the sponsor's last update on 21 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in China. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2013; AzTrials last refreshed its copy on 28 Oct 2026.