Effects of Sequential Treatment Based on Lina/MET After Short-term Intensive Insulin in Newly Diagnosed Type 2 Diabetes

Summary

Short-term intensive insulin therapy(SIIT) is able to reverse β cell dysfunction and induce glycemic remission in patients with newly diagnosed type 2 diabetes. However, proportion of patients with response gradually decreases over time. There is no consensus on which treatment should be given in order to maintain the benefit in glycemic control and β cell recovery. In this multi-center, randomized, controlled study, effects of various sequential treatments ( metformin, linagliptin and combined with both drugs) on long-term blood glucose control as well as preservation of β cell function after SIIT were investigated.

In total, 412 patients with newly diagnosed type 2 diabetes who meet the inclusive criteria will be enrolled in eight centers in China. After baseline assessments, all patients will be treated with insulin pump to achieve and maintain euglycemia for 2 weeks. After completion of intensive treatment, insulin pump will be stopped. Different treatments will be applied to patients for 48 weeks according to randomization: Group A: Linagliptin 5 mg Qd + Metformin 0.5 g bid; Group B: Linagliptin 5 mg Qd; Group C: Metformin 0.5 g bid; Group D: No oral drugs. Primary endpoint is proportion of patients achieving glycosylated hemoglobin A1C \<7% at the end of the study. Secondary endpoints include proportion of patients achieving glycosylated hemoglobin A1C \<6.5% at the end of study; differences in β-cell function , insulin sensitivity, GLP-1 and glucagon secretion among treatment groups, and differences in adverse events among treatment groups.

Conditions

• Type 2 Diabetes Mellitus

Interventions

DRUG

CSII followed by Lina+MET

short-term intensive CSII followed by Linagliptin 5mg qd and Metformin 0.5g bid for 48 weeks

DRUG

CSII followed by Lina

short-term intensive CSII followed by Linagliptin 5mg qd for 48 weeks

DRUG

CSII followed by MET

short-term intensive CSII followed by Metformin 0.5g bid for 48 weeks

DRUG

CSII alone

No OHA is given after short-term intensive CSII

Sponsors & Collaborators

• The Seventh Affiliated Hospital of Sun Yat-sen University

  collaborator OTHER

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Dongguan People's Hospital

  collaborator OTHER_GOV

• Clifford Hospital

  collaborator UNKNOWN

• Guangzhou Panyu Central Hospital

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• Chinese PLA General Hospital

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• Shanghai 10th People's Hospital

  collaborator OTHER

• Shanghai Changzheng Hospital

  collaborator OTHER

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• Huizhou Municipal Central Hospital

  collaborator OTHER

• Sun Yat-sen University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-01

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• China

Study Locations