A Study of Adding Linagliptin to Control Glycemic Variability and HbA1c in Peritoneal Dialysis Patients With Type 2 Diabetes(PDPD) With Premixed Insulin Therapy
- Conditions
- Peritoneal DialysisType 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT03320031
- Lead Sponsor
- Yanbing Li
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 232
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description combined group Linagliptin Drug: linagliptin\&premixed insulin Treated with linagliptin 5mg/d combined with premixed insulin for 12 weeks. combined group Humalog Mix 75/25 Drug: linagliptin\&premixed insulin Treated with linagliptin 5mg/d combined with premixed insulin for 12 weeks. linsulin group Humalog Mix 75/25 Drug: premixed insulin Treated with premixed insulin for 12 weeks.
- Primary Outcome Measures
Name Time Method glucose variability 12 weeks The change from baseline to week 12 in glucose variability indicated by MAGE.
- Secondary Outcome Measures
Name Time Method HbA1c 12 weeks Changes in HbA1c between two groups
insulin dosage 12 weeks Changes in FPG at the end between two groups
body weight 12 weeks Changes in body weight at the end between two groups
hypoglycemia 12 weeks Frequency of hypoglycemia at the end in each gropu
FPG 12 weeks Changes in FPG between two groups
Trial Locations
- Locations (1)
endocrinology department of the first affiliated hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China