Type 2 Diabetes MellitusPhase 4NCT03320031
A Study of Adding Linagliptin to Control Glycemic Variability and HbA1c in Peritoneal Dialysis Patients With Type 2 Diabetes(PDPD) With Premixed Insulin Therapy
A Phase 4 study testing Linagliptin and Humalog Mix 75/25 in people with Type 2 Diabetes Mellitus and Peritoneal Dialysis, run by Yanbing Li at 1 site in China.
Trial summary
In china, there are the most population of type 2 diabetes mellitus (DM) among the world and DM becomes currently the second cause for end-stage renal disease (ESRD). Nearly 50% of insulin-treated PD patients in clinical practice are treated with premixed insulin. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Peritoneal Dialysis
- What is being tested?
- Linagliptin and Humalog Mix 75/25
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2017to Dec 2019
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetic patients who were treated with insulin regimen;
- Ages eligible for study:18 years to 80 years;
- The patients with end-stage kidney disease receiving a regular peritoneal dialysis for at least 3 months;
- HbA1c ranging from 6.5%-10.5% when screening and randomizing ;
- Body mass index ranging from 21 to 35 kg/m2.
Who cannot join
- Having any severe acute or chronic diabetic complications
- Blood aminotransferase level rising up more than 2 times of the upper normal limit
- Any severe cardiac disease, severe systemic diseases or malignant tumour
- Female patients incline to be pregnant
- Being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs
- Poor compliance
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
endocrinology department of the first affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Yanbing Li, MD,PhD, 8602087334331, easd04lyb@126.com
Yanbing Li, MD,PhD
About this study
Official title: A Randomized, Open, Controlled, Parallel Group Study of Adding Linagliptin to Control Glycemic Variability and HbA1c in Peritoneal Dialysis Patients With Type 2 Diabetes(PDPD) With Premixed Insulin Therapy
In china, there are the most population of type 2 diabetes mellitus (DM) among the world and DM becomes currently the second cause for end-stage renal disease (ESRD). Nearly 50% of insulin-treated PD patients in clinical practice are treated with premixed insulin. Glycemic control in them is very difficult to be achieved mainly due to the uremic status of these patients and glucose exposure from peritoneal dialysate, a higher glycemic variability and higher risk of hypoglycemia. Linagliptin, unlike other DPP-4 inhibitors, has a primarily non-renal elimination route, and does not require dose adjustment for any level of impaired renal function. The aim of this study is to evaluate the effect of linagliptin on glucose variability and glycemic control in peritoneal dialysis patients with type 2 diabetes who are inadequately controlled with premixed insulin therapy.
This will be a randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of linagliptin on glucose variability and glycemic control in peritoneal dialysis patients with type 2 diabetes who are inadequately controlled with premixed insulin therapy.which will be conducted in 8 diabetes centres and/or nephropathy departments in China. After a 4-week run- in period, 232 participants are randomized (1:1) to either premixed insulin combined with linagliptin (5mg/d) group (also named combined group) or premixed insulin alone group (also named insulin group) for 12 weeks. Finally, the primary endpoint is glucose variability indicated by MAGE, secondary endpoints include HbA1c, FPG, PPG, LAGE, SDBG, PT10.0, PT3.9, 1h fasting MBG, 3h postprandial MBG, insulin dosage, hypoglycemia and body weight.
- Conditions
- Type 2 Diabetes Mellitus, Peritoneal Dialysis
- Being tested
- Linagliptin, Humalog Mix 75/25
- Keywords
- Linagliptin, premixedinsulin therapy, peritoneal dialysis, glycemic variability
- 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.
LinagliptinDrug
Also called Trajenta
Take linagliptin 5mg a day.
Humalog Mix 75/25Drug
Also called insulin lispro 75/25
Administer subcutaneous premixed insulin twice a day.
| Study group | Role | What they receive |
|---|---|---|
| combined group | Experimental | Drug: linagliptin\&premixed insulin Treated with linagliptin 5mg/d combined with premixed insulin for 12 weeks. Receives: Drug: Linagliptin; Drug: Humalog Mix 75/25 |
| linsulin group | Active comparator | Drug: premixed insulin Treated with premixed insulin for 12 weeks. Receives: Drug: Humalog Mix 75/25 |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose variability
The change from baseline to week 12 in glucose variability indicated by MAGE.
Measured: 12 weeks
Secondary outcomes (5)
HbA1c
Changes in HbA1c between two groups
Measured: 12 weeks
FPG
Changes in FPG between two groups
Measured: 12 weeks
insulin dosage
Changes in FPG at the end between two groups
Measured: 12 weeks
body weight
Changes in body weight at the end between two groups
Measured: 12 weeks
hypoglycemia
Frequency of hypoglycemia at the end in each gropu
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start3 Jun 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanbing Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanbing Li, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320031
- Sponsor's protocol ID
- 2017187
- Status last verified
- Oct 2017
- First submitted
- 20 Oct 2017
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Controlled, Parallel Group Study of Adding Linagliptin to Control Glycemic Variability and HbA1c in Peritoneal Dialysis Patients With Type 2 Diabetes(PDPD) With Premixed Insulin Therapy
- ClinicalTrials.gov ID
- NCT03320031
- Acronym / sponsor ID
- 2017187
- Conditions
- Type 2 Diabetes Mellitus, Peritoneal Dialysis
- Keywords
- Linagliptin, premixedinsulin therapy, peritoneal dialysis, glycemic variability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Yanbing LiUniversity, hospital or other
- Study start
- 3 Jun 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 24 Oct 2017 (actual)
- 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.
In china, there are the most population of type 2 diabetes mellitus (DM) among the world and DM becomes currently the second cause for end-stage renal disease (ESRD). Nearly 50% of insulin-treated PD patients in clinical practice are treated with premixed insulin. Glycemic control in them is very difficult to be achieved mainly due to the uremic status of these patients and glucose exposure from peritoneal dialysate, a higher glycemic variability and higher risk of hypoglycemia. Linagliptin, unlike other DPP-4 inhibitors, has a primarily non-renal elimination route, and does not require dose adjustment for any level of impaired renal function. The aim of this study is to evaluate the effect of linagliptin on glucose variability and glycemic control in peritoneal dialysis patients with type 2 diabetes who are inadequately controlled with premixed insulin therapy.
This will be a randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of linagliptin on glucose variability and glycemic control in peritoneal dialysis patients with type 2 diabetes who are inadequately controlled with premixed insulin therapy.which will be conducted in 8 diabetes centres and/or nephropathy departments in China. After a 4-week run- in period, 232 participants are randomized (1:1) to either premixed insulin combined with linagliptin (5mg/d) group (also named combined group) or premixed insulin alone group (also named insulin group) for 12 weeks. Finally, the primary endpoint is glucose variability indicated by MAGE, secondary endpoints include HbA1c, FPG, PPG, LAGE, SDBG, PT10.0, PT3.9, 1h fasting MBG, 3h postprandial MBG, insulin dosage, hypoglycemia and body weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined group | Experimental | Drug: Linagliptin, Drug: Humalog Mix 75/25Drug: linagliptin\&premixed insulin Treated with linagliptin 5mg/d combined with premixed insulin for 12 weeks. |
| linsulin group | Active comparator | Drug: Humalog Mix 75/25Drug: premixed insulin Treated with premixed insulin for 12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetic patients who were treated with insulin regimen;
- Ages eligible for study:18 years to 80 years;
- The patients with end-stage kidney disease receiving a regular peritoneal dialysis for at least 3 months;
- HbA1c ranging from 6.5%-10.5% when screening and randomizing ;
- Body mass index ranging from 21 to 35 kg/m2.
Key exclusion criteria (6 listed)
- Having any severe acute or chronic diabetic complications
- Blood aminotransferase level rising up more than 2 times of the upper normal limit
- Any severe cardiac disease, severe systemic diseases or malignant tumour
- Female patients incline to be pregnant
- Being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs
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 |
|---|---|---|
| LinagliptinAlso: TrajentaTake linagliptin 5mg a day. | Drug | combined group |
| Humalog Mix 75/25Also: insulin lispro 75/25Administer subcutaneous premixed insulin twice a day. | Drug | combined group, linsulin group |
Primary outcome
glucose variability
Time frame: 12 weeks
The change from baseline to week 12 in glucose variability indicated by MAGE.
5 secondary outcomes
HbA1c
Time frame: 12 weeks
FPG
Time frame: 12 weeks
insulin dosage
Time frame: 12 weeks
body weight
Time frame: 12 weeks
hypoglycemia
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Linagliptin and Humalog Mix 75/25 in people with Type 2 Diabetes Mellitus and Peritoneal Dialysis, run by Yanbing Li at 1 site 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 6 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 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Yanbing Li, MD,PhD (+86-13925111691, easd04lyb@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glucose variability (time frame: 12 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 24 Oct 2017.