Type 2 Diabetes MellitusNCT01588743
Effects of Short-term Intensive Insulin Therapy in Newly Diagnosed Type 2 Diabetes Patients
A study testing insulin aspart in people with Type 2 Diabetes Mellitus, run by Li Guangwei.
Trial summary
It is well known that Long-term hyperglycemia (also known as glucose toxicity) contribute to impairment in islet β-cell function and development of insulin resistance. A growing body of evidence also indicates that this impairment inβ-cell function and insulin action could be restored after hyperglycemia is corrected… Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- insulin aspart
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Dec 2012
- Phase
- Interventional
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 25 to 60 years old
- Duration of diabetes: newly diagnosed type 2 diabetes (duration of diabetes less than 1 year) and haven't taken any antidiabetic medication.
- Fasting blood glucose is above 11.0mmol/L.
- Half of the patients with BMI below 24 and the other half with BMI above 24.
Who cannot join
- type 1 diabetes mellitus
- type 2 diabetes patients with intercurrent illness (ketoacidosis, infection or any other acute stress)
- Presence of auto-immune disease, hepatic or renal disease or any concomitant disease is not allowed.
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months.
About this study
Official title: Effects of Short-term Intensive Insulin Therapy on Insulin Resistance and Insulin Secretion in Newly Diagnosed Lean and Obese Type 2 Diabetes Patients
It is well known that Long-term hyperglycemia (also known as glucose toxicity) contribute to impairment in islet β-cell function and development of insulin resistance. A growing body of evidence also indicates that this impairment inβ-cell function and insulin action could be restored after hyperglycemia is corrected by short-term intensive insulin therapy. In this study, we are determined to use the golden standard of insulin sensitivity evaluation in vivo-hyperinsulinemia euglycemic glucose clamp-to estimate insulin resistance improvement in patients before and after intensive insulin therapy, investigate first phase insulin secretion to evaluate β-cell function, examine the changes in insulin resistance and insulin secretion resulting from normalization of plasma glucose levels in both lean and obese patients by insulin pump therapy.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- insulin aspart
- 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 aspartDrug
Insulin Aspart will be administrated by insulin pump with an initial dose of 0.4-0.6u/kg body weight, of which 50% basal rate and the other 50% bolus dose. Time interval for administration will be as follows: 0-3Am-9Am-12Am-5Pm-9Pm-0Am. Specific adjustment will be made according to individual difference.
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC75-120 of Glucose Infusion Rate (GIR)
Measured: after 2 weeks insulin pump intensive therapy, and one-year follow-up after termination of treatments
Secondary outcomes (1)
AUC0-10 of Acute Insulin Response (AIR) during IVGTT
Measured: after 2 weeks insulin pump intensive therapy, and one-year follow-up after termination of treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startOct 2008
- Primary completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Guangwei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Guangwei, China-Japan Friendship Hospital
- Investigators
- Guangwei Li, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588743
- Sponsor's protocol ID
- Prof. Li Guangwei
- Status last verified
- Apr 2012
- First submitted
- 27 Apr 2012
- Last updated
- 1 May 2012
- Results posted
- No
Publications
Wang H, Kuang J, Xu M, Gao Z, Li Q, Liu S, Zhang F, Yu Y, Liang Z, Zhao W, Yang G, Li L, Wang Y, Li G. Predictors of Long-Term Glycemic Remission After 2-Week Intensive Insulin Treatment in Newly Diagnosed Type 2 Diabetes. J Clin Endocrinol Metab. 2019 Jun 1;104(6):2153-2162. doi: 10.1210/jc.2018-01468.
PubMed 30629195
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Short-term Intensive Insulin Therapy on Insulin Resistance and Insulin Secretion in Newly Diagnosed Lean and Obese Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT01588743
- Acronym / sponsor ID
- Prof. Li Guangwei
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Li GuangweiUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2012 (estimated)
- First posted
- 1 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is well known that Long-term hyperglycemia (also known as glucose toxicity) contribute to impairment in islet β-cell function and development of insulin resistance. A growing body of evidence also indicates that this impairment inβ-cell function and insulin action could be restored after hyperglycemia is corrected by short-term intensive insulin therapy. In this study, we are determined to use the golden standard of insulin sensitivity evaluation in vivo-hyperinsulinemia euglycemic glucose clamp-to estimate insulin resistance improvement in patients before and after intensive insulin therapy, investigate first phase insulin secretion to evaluate β-cell function, examine the changes in insulin resistance and insulin secretion resulting from normalization of plasma glucose levels in both lean and obese patients by insulin pump therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 25 to 60 years old
- Duration of diabetes: newly diagnosed type 2 diabetes (duration of diabetes less than 1 year) and haven't taken any antidiabetic medication.
- Fasting blood glucose is above 11.0mmol/L.
- Half of the patients with BMI below 24 and the other half with BMI above 24.
Key exclusion criteria (4 listed)
- type 1 diabetes mellitus
- type 2 diabetes patients with intercurrent illness (ketoacidosis, infection or any other acute stress)
- Presence of auto-immune disease, hepatic or renal disease or any concomitant disease is not allowed.
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months.
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 |
|---|---|---|
| insulin aspartInsulin Aspart will be administrated by insulin pump with an initial dose of 0.4-0.6u/kg body weight, of which 50% basal rate and the other 50% bolus dose. Time interval for administration will be as follows: 0-3Am-9Am-12Am-5Pm-9Pm-0Am. Specific adjustment will be made according to individual difference. | Drug | – |
Primary outcome
AUC75-120 of Glucose Infusion Rate (GIR)
Time frame: after 2 weeks insulin pump intensive therapy, and one-year follow-up after termination of treatments
1 secondary outcome
AUC0-10 of Acute Insulin Response (AIR) during IVGTT
Time frame: after 2 weeks insulin pump intensive therapy, and one-year follow-up after termination of treatments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2012.
- Derived from this study: PubMed 30629195Wang H, Kuang J, Xu M, Gao Z, Li Q, Liu S, Zhang F, Yu Y, Liang Z, Zhao W, Yang G, Li L, Wang Y, Li G. Predictors of Long-Term Glycemic Remission After 2-Week Intensive Insulin Treatment in Newly Diagnosed Type 2 Diabetes. J Clin Endocrinol Metab. 2019 Jun 1;104(6):2153-2162. doi: 10.1210/jc.2018-01468.
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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.
Guangwei Li principal investigator
China-Japan Friendship Hospital
Questions about this trial
What is this clinical trial studying?
A study testing insulin aspart in people with Type 2 Diabetes Mellitus, run by Li Guangwei.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
AUC75-120 of Glucose Infusion Rate (GIR) (time frame: after 2 weeks insulin pump intensive therapy, and one-year follow-up after termination of treatments). 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 NCT01588743, which also lists 1 linked publication.
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 1 May 2012.