NCT06329882

Brief Summary

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease characterized by hyperglycemia, weight loss, and cardio-metabolic complications. T2DM develops due to the progression of insulin resistance (IR), impairment of insulin insensitivity, and failure of the pancreatic β-cells to release sufficient amount of insulin in response to glucose burden

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2024

Longer than P75 for phase_1 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

March 30, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2026

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

March 9, 2024

Last Update Submit

April 3, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in glycemic profile

    measurement of fasting blood glucose (FBG)

    3 months

  • Change in glycemic profile

    measurement of glycated hemoglobin

    3 months

Study Arms (2)

control group

ACTIVE COMPARATOR

patients were on sitagliptin 100mg /day monotherapy

Drug: Sitagliptin 100mg

Comparative group

ACTIVE COMPARATOR

patients were on sitagliptin 100mg /day monotherapy plus doxycycline 100 mg

Drug: Sitagliptin 100mgDrug: Doxycyclin

Interventions

Sitagliptin is used along with diet and exercise and sometimes with other medications to lower blood sugar levels in adults with type 2 diabetes

Comparative groupcontrol group

Doxycycline belongs to the class of medicines known as tetracycline antibiotics. It works by killing bacteria or preventing their growth.

Comparative group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female sex more than 40 years old Newly diagnosed type II diabetes. HbA1c more than 6.5

You may not qualify if:

  • Patient with chronic kidney disease, hepatic disorders, mental and psychiatric disorders, pregnancy, and lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta Unuversity

Tanta, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin PhosphateDoxycycline

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Masking Details
open label
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: open label
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Teaching assisstant

Study Record Dates

First Submitted

March 9, 2024

First Posted

March 26, 2024

Study Start

March 30, 2024

Primary Completion

March 20, 2026

Study Completion

April 20, 2026

Last Updated

April 4, 2025

Record last verified: 2025-04

Locations